ECLIPSE: Safety and Efficacy of Cryoablation for Metastatic Lung Tumors
Study Details
Study Description
Brief Summary
ECLIPSE will evaluate the safety and efficacy of cryoablation therapy used to treat tumors less than or equal to 3.5 centimeters (cm) in participants with pulmonary metastatic disease.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
ECLIPSE is a treatment, Phase 1 multicenter, prospective, single-arm study with participants serving as their own control. This study is to enroll participants who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5 cm. Participants will be followed for 5 years post their cryoablation procedure.
Cryoablation is the process of destroying tissue by the application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves), chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer), proctology (colon/rectal), and urology (kidney).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Cryoablation Participants will undergo a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators. No more than 3 tumors in 1 lung can be treated in a single session, and no more than 5 total lung tumors (across both lungs) can be treated during the study. |
Device: Cryoablation
Application of extremely cold temperatures to the identified tumor(s).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60 [Baseline and Month 60]
Local tumor control was achieved if either the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or <25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.
Secondary Outcome Measures
- Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48 [Baseline and Months 3, 6, 12, 24, 36, and 48]
Local tumor control was achieved if the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of the greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or <25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used.
- Overall Disease-Specific Participant Survival Post-Cryoablation [Up to Month 60]
Disease-specific survival was analyzed as time in days from study cryoablation to participant death due to lung cancer. All deaths with documented lung disease progression were categorized as disease-specific deaths for this analysis. Participants who were alive were censored at the date of their last visit. Participants who died from causes other than lung cancer and did not have documented disease progression were censored at the time of death.
- Time in Days to Disease Recurrence or Progression Following Study Cryoablation [Baseline (0 days), Week 1 (7 days), and Months 3 (90 days), 6 (180 days), 12 (365 days), 24 (730 days), 36 (1095 days), 48 (1460 days), and 60 (1825 days)]
Disease recurrence or progression will be determined locally by evidence of an increase in tumor size and/or contrast enhancement that met the definition of local tumor failure. Local tumor failure defined as a >20% increase from baseline in the sum of the largest diameter of all targeted tumors. Participants without disease recurrence or progression were censored at the date of their last visit or their date of death due to any cause. The percentage of participants with disease recurrence or progression after the study cryoablation procedure at the specified number of days is presented.
- Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 [Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60]
ECOG Performance Status defined as a set of criteria with corresponding scores used by the Investigator to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. ECOG Performance Status Scoring: 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead.
- Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 [Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60]
The KPS Scale is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities. KPS may be used to determine a participant's prognosis, to measure changes in a participant's ability to function.
- Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60 [Baseline, Months 1, 3, 6, 12, 24, 36, 48, and 60]
The SF-12 is a shortened version of the well-known SF-36. The SF-12 assesses eight domains (physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality and general health perception). Assessments were made by examining the change in the baseline scores to those reported post-operatively. The scores range from 0 to 100. A higher value indicates a better quality of life of the participant.
- Cryoablation Technical Success of the Study Cryoablation Procedure [Up to 60 months]
A technically successful treatment was defined by an ablation volume encompassing the tumor with at least a 5 mm margin. Technical success was calculated on a per tumor level as well as a participant level. To be considered a technical success on a participant level, all tumors treated during the baseline procedure were required to meet the technical success criteria (that is, an ablation volume encompassing the tumor with at least a 5 mm margin).
- Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE) [Baseline up to 30 days post-cryoablation]
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. UADE was any serious adverse effect, any life-threatening problem or death caused by or associated with a device, if it was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device. The AEs that are presented were considered related to the cryoablation procedure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
- Metastatic Disease Spread as Measured by Imaging [Months 3, 6, 12, 24, 36, 48, and 60]
Evidence of additional metastatic disease post cryoablation procedure as measured by imaging is presented.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant must be at least 18 years old.
-
Participant has signed a written informed consent.
-
Participant presents with Stage 4 pulmonary metastatic disease with metastatic disease previously confirmed by prior biopsy or confirmed on imaging with known primary disease.
-
Participant has up to 3 local metastases unilaterally targeted by cryoablation. Maximum of 5 total pulmonary tumors bilaterally.
-
Targeted tumor(s) defined as intra pulmonary or pleural with a maximum size of 3.5 cm.
-
The target tumor is determined (by CT/MRI) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs and structures.
-
Eastern Cooperative Oncology Group (ECOG) score of 0-2.
-
Karnofsky Performance Scale (KPS) score ≥60.
-
Platelet count >50,000/cubed millimeters (mm^3) within 60 days prior to study treatment.
-
International normalized ratio (INR) less than 1.5 within 60 days prior to study treatment.
-
Participant has a life expectancy of >3 months.
-
Participant is clinically suitable for cryoablation procedure.
Exclusion Criteria:
-
Participant's primary cancer is lung cancer.
-
Participant is unable to lie flat or has respiratory distress at rest.
-
Participant has uncontrolled coagulopathy or bleeding disorders.
-
Participant has had chemotherapy with neutropenia to levels as confirmed by absolute neutrophil count (ANC) of less than 1000 that produce increase risk for the cryoablation procedure.
-
Participant has a history of an allergic reaction to iodine injections or to shellfish.
-
Participant has evidence of active systemic, pulmonary, or pericardial infection.
-
Participant has a debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment or follow up.
-
Participant is currently participating in other experimental studies that could affect the primary endpoint.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ronald Regan UCLA Medical Center | Los Angeles | California | United States | 90095 |
2 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
3 | Mayo Clinic Rochester | Rochester | Minnesota | United States | 55905 |
4 | Institut Gustave Roussy | Villejuif | Cedex | France | 94805 |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Study Chair: Hiran Fernando, MD, Boston Medical Center
Study Documents (Full-Text)
More Information
Publications
- Ahmed A, Littrup P. Percutaneous cryotherapy of the thorax: safety considerations for complex cases. AJR Am J Roentgenol. 2006 Jun;186(6):1703-6.
- Asimakopoulos G, Beeson J, Evans J, Maiwand MO. Cryosurgery for malignant endobronchial tumors: analysis of outcome. Chest. 2005 Jun;127(6):2007-14.
- Blazeby JM, Avery K, Sprangers M, Pikhart H, Fayers P, Donovan J. Health-related quality of life measurement in randomized clinical trials in surgical oncology. J Clin Oncol. 2006 Jul 1;24(19):3178-86. Review.
- Gillams A. Lung tumour ablation - where are we now? Cancer Imaging. 2008 Apr 22;8:116-7. doi: 10.1102/1470-7330.2008.0015.
- Kawamura M, Izumi Y, Tsukada N, Asakura K, Sugiura H, Yashiro H, Nakano K, Nakatsuka S, Kuribayashi S, Kobayashi K. Percutaneous cryoablation of small pulmonary malignant tumors under computed tomographic guidance with local anesthesia for nonsurgical candidates. J Thorac Cardiovasc Surg. 2006 May;131(5):1007-13.
- Wang H, Littrup PJ, Duan Y, Zhang Y, Feng H, Nie Z. Thoracic masses treated with percutaneous cryotherapy: initial experience with more than 200 procedures. Radiology. 2005 Apr;235(1):289-98.
- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33.
- CUC10-LNG06
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Cryoablation |
---|---|
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. |
Period Title: Overall Study | |
STARTED | 40 |
Intent-to-Treat (ITT) Population | 40 |
COMPLETED | 17 |
NOT COMPLETED | 23 |
Baseline Characteristics
Arm/Group Title | Cryoablation |
---|---|
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. |
Overall Participants | 40 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
62.6
(13.3)
|
Sex: Female, Male (Count of Participants) | |
Female |
16
40%
|
Male |
24
60%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
2
5%
|
Not Hispanic or Latino |
19
47.5%
|
Unknown or Not Reported |
19
47.5%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
1
2.5%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
2
5%
|
White |
17
42.5%
|
More than one race |
1
2.5%
|
Unknown or Not Reported |
19
47.5%
|
Eastern Cooperative Oncology Group (ECOG) Performance Status (score on a scale) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [score on a scale] |
0.3
(0.5)
|
Physical Function as Assessed by the Karnofsky Performance Status (KPS) Scale (score on a scale) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [score on a scale] |
95.5
(8.1)
|
Quality of Life Over Time as Assessed by the Short Form-12 (SF-12) Generic Measure (score on a scale) [Mean (Standard Deviation) ] | |
Physical Functioning |
71.2
(34.9)
|
Role Physical |
62.1
(29.7)
|
Bodily Pain |
77.3
(26.8)
|
Social Functioning |
80.5
(26.7)
|
Mental Health |
69.5
(18.2)
|
Role Emotional |
78.4
(21.0)
|
Vitality |
57.8
(22.4)
|
General Health Perception |
63.9
(23.3)
|
Outcome Measures
Title | Local Tumor Control for Each Index Tumor as Measured by Imaging at Month 60 |
---|---|
Description | Local tumor control was achieved if either the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or <25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used. |
Time Frame | Baseline and Month 60 |
Outcome Measure Data
Analysis Population Description |
---|
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point. |
Arm/Group Title | Cryoablation |
---|---|
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. |
Measure Participants | 40 |
Measure Tumors | 60 |
Local Control, Month 60 |
80.0
|
Complete Response, Month 60 |
45.0
|
Partial Response, Month 60 |
15.0
|
Stable Disease, Month 60 |
20.0
|
Local Failure, Month 60 |
20.0
|
Title | Local Tumor Control for Each Index Tumor as Measured by Imaging at Months 3, 6, 12, 24, 36, and 48 |
---|---|
Description | Local tumor control was achieved if the greatest trans-axial diameter of a treated tumor was ≤20% greater than at the pre-procedure assessment (per-tumor assessment) or if the sum of the greatest trans-axial diameters of all treated tumors for a participant was ≤20% greater than the sum for the pre-procedure assessment of those tumors (per-participant assessment). Complete Response defined as tumor disappearance (scar) or <25% of original size. If tumor/ablation zone had likely disappeared, the measurement was recorded as 0 mm; if tumor/ablation zone was present but too small to measure, the measurement was recorded as 5 mm. Partial Response defined as greater than 30% decrease in sum of the largest diameter of all targeted tumors. Stable Disease defined as less than 30% decrease in sum of the largest diameter of all targeted tumors. Local Failure defined as greater than 20% increase in the sum of the largest diameter of all targeted tumors. Worst response per participant was used. |
Time Frame | Baseline and Months 3, 6, 12, 24, 36, and 48 |
Outcome Measure Data
Analysis Population Description |
---|
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point. |
Arm/Group Title | Cryoablation |
---|---|
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. |
Measure Participants | 40 |
Measure Tumors | 60 |
Local Control, Month 3 |
46.4
|
Local Control, Month 6 |
66.7
|
Local Control, Month 12 |
80.4
|
Local Control, Month 24 |
87.5
|
Local Control, Month 48 |
90.9
|
Local Control, Month 36 |
90.3
|
Complete Response, Month 3 |
5.4
|
Complete Response, Month 6 |
15.8
|
Complete Response, Month 12 |
23.5
|
Complete Response, Month 24 |
40.0
|
Complete Response, Month 36 |
38.7
|
Complete Response, Month 48 |
40.9
|
Partial Response, Month 3 |
3.6
|
Partial Response, Month 6 |
10.5
|
Partial Response, Month 12 |
15.7
|
Partial Response, Month 24 |
10.0
|
Partial Response, Month 36 |
16.1
|
Partial Response, Month 48 |
22.7
|
Stable Disease, Month 3 |
37.5
|
Stable Disease, Month 6 |
40.4
|
Stable Disease, Month 12 |
41.2
|
Stable Disease, Month 24 |
37.5
|
Stable Disease, Month 36 |
35.5
|
Stable Disease, Month 48 |
27.3
|
Local Failure, Month 3 |
53.6
|
Local Failure, Month 6 |
33.3
|
Local Failure, Month 12 |
19.6
|
Local Failure, Month 24 |
12.5
|
Local Failure, Month 36 |
9.7
|
Local Failure, Month 48 |
9.1
|
Title | Overall Disease-Specific Participant Survival Post-Cryoablation |
---|---|
Description | Disease-specific survival was analyzed as time in days from study cryoablation to participant death due to lung cancer. All deaths with documented lung disease progression were categorized as disease-specific deaths for this analysis. Participants who were alive were censored at the date of their last visit. Participants who died from causes other than lung cancer and did not have documented disease progression were censored at the time of death. |
Time Frame | Up to Month 60 |
Outcome Measure Data
Analysis Population Description |
---|
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point. |
Arm/Group Title | Cryoablation |
---|---|
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. |
Measure Participants | 40 |
Week 1 |
100
250%
|
Month 1 |
100
250%
|
Month 3 |
100
250%
|
Month 6 |
100
250%
|
Month 12 |
100
250%
|
Month 24 |
86.5
216.3%
|
Month 36 |
74.8
187%
|
Month 48 |
71.5
178.8%
|
Month 60 |
55.3
138.3%
|
Title | Time in Days to Disease Recurrence or Progression Following Study Cryoablation |
---|---|
Description | Disease recurrence or progression will be determined locally by evidence of an increase in tumor size and/or contrast enhancement that met the definition of local tumor failure. Local tumor failure defined as a >20% increase from baseline in the sum of the largest diameter of all targeted tumors. Participants without disease recurrence or progression were censored at the date of their last visit or their date of death due to any cause. The percentage of participants with disease recurrence or progression after the study cryoablation procedure at the specified number of days is presented. |
Time Frame | Baseline (0 days), Week 1 (7 days), and Months 3 (90 days), 6 (180 days), 12 (365 days), 24 (730 days), 36 (1095 days), 48 (1460 days), and 60 (1825 days) |
Outcome Measure Data
Analysis Population Description |
---|
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point. |
Arm/Group Title | Cryoablation |
---|---|
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. |
Measure Participants | 40 |
Baseline |
0
0%
|
Week 1 (7 days) |
0
0%
|
Month 1 (30 days) |
0
0%
|
Month 3 (90 days) |
0
0%
|
Month 6 (180 days) |
2.5
6.3%
|
Month 12 (365 days) |
5.1
12.8%
|
Month 24 (730 days) |
10.7
26.8%
|
Month 36 (1095 days) |
10.7
26.8%
|
Month 48 (1460 days) |
10.7
26.8%
|
Month 60 (1825 days) |
21.8
54.5%
|
Title | Change From Baseline in ECOG Performance Status at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 |
---|---|
Description | ECOG Performance Status defined as a set of criteria with corresponding scores used by the Investigator to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. ECOG Performance Status Scoring: 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (for example, light house work, office work); 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3=Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead. |
Time Frame | Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 |
Outcome Measure Data
Analysis Population Description |
---|
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point. |
Arm/Group Title | Cryoablation |
---|---|
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. |
Measure Participants | 40 |
Change at Week 1 |
0.1
(0.5)
|
Change at Month 1 |
0
(0.4)
|
Change at Month 3 |
0.2
(0.4)
|
Change at Month 6 |
0.1
(0.4)
|
Change at Month 12 |
0.2
(0.6)
|
Change at Month 24 |
0.2
(0.6)
|
Change at Month 36 |
-0.1
(0.5)
|
Change at Month 48 |
0.2
(0.8)
|
Change at Month 60 |
0.6
(1.0)
|
Title | Change From Baseline in Physical Function as Assessed by the KPS Scale at Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 |
---|---|
Description | The KPS Scale is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities. KPS may be used to determine a participant's prognosis, to measure changes in a participant's ability to function. |
Time Frame | Baseline, Week 1 and Months 3, 6, 12, 24, 36, 48, and 60 |
Outcome Measure Data
Analysis Population Description |
---|
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point. |
Arm/Group Title | Cryoablation |
---|---|
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. |
Measure Participants | 40 |
Baseline |
95.5
(8.1)
|
Change at Week 1 |
-1.8
(6.1)
|
Change at Month 1 |
-0.9
(5.3)
|
Change at Month 3 |
-1.6
(6.3)
|
Change at Month 6 |
0.3
(7.2)
|
Change at Month 12 |
-0.5
(8.4)
|
Change at Month 24 |
4.4
(7.3)
|
Change at Month 36 |
7.8
(4.4)
|
Change at Month 48 |
5.0
(5.5)
|
Change at Month 60 |
6.7
(5.8)
|
Title | Change From Baseline in Quality of Life Over Time as Assessed by the SF-12 Generic Measure at Months 1, 3, 6, 12, 24, 36, 48, and 60 |
---|---|
Description | The SF-12 is a shortened version of the well-known SF-36. The SF-12 assesses eight domains (physical functioning, role limitations due to physical health problems, bodily pain, social functioning, general mental health, role limitations due to emotional problems, vitality and general health perception). Assessments were made by examining the change in the baseline scores to those reported post-operatively. The scores range from 0 to 100. A higher value indicates a better quality of life of the participant. |
Time Frame | Baseline, Months 1, 3, 6, 12, 24, 36, 48, and 60 |
Outcome Measure Data
Analysis Population Description |
---|
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point. |
Arm/Group Title | Cryoablation |
---|---|
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. |
Measure Participants | 40 |
Physical Functioning, Change at Month 1 |
-10.0
(24.2)
|
Physical Functioning, Change at Month 3 |
-12.0
(24.4)
|
Physical Functioning, Change at Month 6 |
-12.5
(33.0)
|
Physical Functioning, Change at Month 12 |
-23.9
(38.0)
|
Physical Functioning, Change at Month 24 |
-10.4
(44.5)
|
Physical Functioning, Change at Month 36 |
-12.5
(31.7)
|
Physical Functioning, Change at Month 48 |
-10.7
(31.8)
|
Physical Functioning, Change at Month 60 |
-12.5
(54.2)
|
Role Physical, Change at Month 1 |
4.2
(24.2)
|
Role Physical, Change at Month 3 |
-1.9
(21.0)
|
Role Physical, Change at Month 6 |
-0.4
(19.7)
|
Role Physical, Change at Month 12 |
-2.2
(26.8)
|
Role Physical, Change at Month 24 |
5.2
(23.5)
|
Role Physical, Change at Month 36 |
5.0
(25.8)
|
Role Physical, Change at Month 48 |
3.6
(35.9)
|
Role Physical, Change at Month 60 |
-4.2
(25.8)
|
Bodily Pain, Change at Month 1 |
-9.2
(25.8)
|
Bodily Pain, Change at Month 3 |
-3.7
(21.6)
|
Bodily Pain, Change at Month 6 |
-9.8
(24.9)
|
Bodily Pain, Change at Month 12 |
-7.6
(19.1)
|
Bodily Pain, Change at Month 24 |
-18.8
(32.2)
|
Bodily Pain, Change at Month 36 |
-5.0
(30.7)
|
Bodily Pain, Change at Month 48 |
0
(28.9)
|
Bodily Pain, Change at Month 60 |
-8.3
(49.2)
|
Social Functioning, Change at Month 1 |
-8.6
(26.1)
|
Social Functioning, Change at Month 3 |
-3.7
(23.7)
|
Social Functioning, Change at Month 6 |
-4.6
(22.0)
|
Social Functioning, Change at Month 12 |
-11.4
(24.1)
|
Social Functioning, Change at Month 24 |
-12.5
(32.9)
|
Social Functioning, Change at Month 36 |
-2.5
(24.9)
|
Social Functioning, Change at Month 48 |
-3.6
(39.3)
|
Social Functioning, Change at Month 60 |
-12.5
(37.9)
|
Mental Health, Change at Month 1 |
1.7
(16.3)
|
Mental Health, Change at Month 3 |
0.9
(12.0)
|
Mental Health, Change at Month 6 |
-1.4
(10.6)
|
Mental Health, Change at Month 12 |
-0.6
(20.6)
|
Mental Health, Change at Month 24 |
-3.1
(17.0)
|
Mental Health, Change at Month 36 |
3.8
(15.6)
|
Mental Health, Change at Month 48 |
8.9
(9.4)
|
Mental Health, Change at Month 60 |
0
(13.7)
|
Role Emotional, Change at Month 1 |
-3.3
(20.5)
|
Role Emotional, Change at Month 3 |
-11.6
(23.0)
|
Role Emotional, Change at Month 6 |
-2.7
(24.4)
|
Role Emotional, Change at Month 12 |
-3.8
(21.1)
|
Role Emotional, Change at Month 24 |
-11.5
(24.1)
|
Role Emotional, Change at Month 36 |
-11.3
(27.9)
|
Role Emotional, Change at Month 48 |
-8.9
(15.7)
|
Role Emotional, Change at Month 60 |
-22.9
(26.7)
|
Vitality, Change at Month 1 |
-6.0
(22.8)
|
Vitality, Change at Month 3 |
-9.3
(19.8)
|
Vitality, Change at Month 6 |
-6.5
(22.6)
|
Vitality, Change at Month 12 |
-10.2
(24.0)
|
Vitality, Change at Month 24 |
-14.6
(22.5)
|
Vitality, Change at Month 36 |
-2.5
(27.5)
|
Vitality, Change at Month 48 |
-7.1
(23.8)
|
Vitality, Change at Month 60 |
-4.2
(29.2)
|
General Health Perception, Change at Month 1 |
-3.8
(19.9)
|
General Health Perception, Change at Month 3 |
2.4
(26.1)
|
General Health Perception, Change at Month 6 |
0
(23.5)
|
General Health Perception, Change at Month 12 |
-5.2
(31.4)
|
General Health Perception, Change at Month 24 |
-11.3
(22.2)
|
General Health Perception, Change at Month 36 |
-14.5
(24.1)
|
General Health Perception, Change at Month 48 |
-14.3
(28.9)
|
General Health Perception, Change at Month 60 |
-22.5
(33.6)
|
Title | Cryoablation Technical Success of the Study Cryoablation Procedure |
---|---|
Description | A technically successful treatment was defined by an ablation volume encompassing the tumor with at least a 5 mm margin. Technical success was calculated on a per tumor level as well as a participant level. To be considered a technical success on a participant level, all tumors treated during the baseline procedure were required to meet the technical success criteria (that is, an ablation volume encompassing the tumor with at least a 5 mm margin). |
Time Frame | Up to 60 months |
Outcome Measure Data
Analysis Population Description |
---|
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population). |
Arm/Group Title | Cryoablation |
---|---|
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. |
Measure Participants | 40 |
Measure Tumors | 60 |
Number [percentage of tumors] |
100
|
Title | Number of Participants With an Intra- or Post-operative Adverse Event (AE), a Serious AE, or an Unanticipated Adverse Device Effect (UADE) |
---|---|
Description | An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study. Serious AEs include death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent the previously listed serious outcomes. UADE was any serious adverse effect, any life-threatening problem or death caused by or associated with a device, if it was not previously identified in nature, severity, or degree of incidence in the application; or any other unanticipated serious problem associated with a device. The AEs that are presented were considered related to the cryoablation procedure. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. |
Time Frame | Baseline up to 30 days post-cryoablation |
Outcome Measure Data
Analysis Population Description |
---|
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population). |
Arm/Group Title | Cryoablation |
---|---|
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. |
Measure Participants | 40 |
Intra-operative nonserious AE (NSAE) |
23
57.5%
|
Post-operative NSAE, prior to discharge |
9
22.5%
|
Post-operative NSAE within 30 days of procedure |
19
47.5%
|
Serious AE |
6
15%
|
UADE |
0
0%
|
Title | Metastatic Disease Spread as Measured by Imaging |
---|---|
Description | Evidence of additional metastatic disease post cryoablation procedure as measured by imaging is presented. |
Time Frame | Months 3, 6, 12, 24, 36, 48, and 60 |
Outcome Measure Data
Analysis Population Description |
---|
Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population) with available data at the respective time point. |
Arm/Group Title | Cryoablation |
---|---|
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. |
Measure Participants | 40 |
Month 3 |
16
40%
|
Month 6 |
14
35%
|
Month 12 |
14
35%
|
Month 24 |
10
25%
|
Month 36 |
9
22.5%
|
Month 48 |
7
17.5%
|
Month 60 |
6
15%
|
Adverse Events
Time Frame | Baseline up to Month 60 | |
---|---|---|
Adverse Event Reporting Description | Participants for whom cryoablation via Galil Medical Cryoablation System was attempted or performed (ITT Population). | |
Arm/Group Title | Cryoablation | |
Arm/Group Description | Participants underwent a cryoablation procedure with the Galil Medical Cryoablation System according to the manufacturer's guidelines. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators. No more than 3 tumors in 1 lung were treated in a single session, and no more than 5 total lung tumors (across both lungs) were treated during the study. | |
All Cause Mortality |
||
Cryoablation | ||
Affected / at Risk (%) | # Events | |
Total | 20/40 (50%) | |
Serious Adverse Events |
||
Cryoablation | ||
Affected / at Risk (%) | # Events | |
Total | 6/40 (15%) | |
Infections and infestations | ||
Appendicitis | 1/40 (2.5%) | |
Injury, poisoning and procedural complications | ||
Vascular access complication | 1/40 (2.5%) | |
Respiratory, thoracic and mediastinal disorders | ||
Pneumothorax | 3/40 (7.5%) | |
Vascular disorders | ||
Bilateral subdural hematoma | 1/40 (2.5%) | |
Other (Not Including Serious) Adverse Events |
||
Cryoablation | ||
Affected / at Risk (%) | # Events | |
Total | 32/40 (80%) | |
Gastrointestinal disorders | ||
Nausea | 1/40 (2.5%) | |
Vomiting | 1/40 (2.5%) | |
General disorders | ||
Fever | 1/40 (2.5%) | |
Flu like symptoms | 1/40 (2.5%) | |
Non-cardiac chest pain | 1/40 (2.5%) | |
Pain | 1/40 (2.5%) | |
Pain at procedure site | 2/40 (5%) | |
Infections and infestations | ||
Lung infection | 1/40 (2.5%) | |
Skin infection | 1/40 (2.5%) | |
Injury, poisoning and procedural complications | ||
Burn | 1/40 (2.5%) | |
Intraoperative hemorrhage | 2/40 (5%) | |
Postoperative hemorrhage | 1/40 (2.5%) | |
Musculoskeletal and connective tissue disorders | ||
Back Pain | 2/40 (5%) | |
Chest wall pain | 1/40 (2.5%) | |
Pain in left arm | 1/40 (2.5%) | |
Nervous system disorders | ||
Headache | 1/40 (2.5%) | |
Reproductive system and breast disorders | ||
Vaginal inflammation | 1/16 (6.3%) | |
Respiratory, thoracic and mediastinal disorders | ||
Alveolar hemorrhage | 1/40 (2.5%) | |
Atelectasis | 2/40 (5%) | |
Cough | 3/40 (7.5%) | |
Hemoptysis | 1/40 (2.5%) | |
Pleural effusion | 11/40 (27.5%) | |
Pleural hemorrhage | 2/40 (5%) | |
Pneumothorax | 19/40 (47.5%) | |
Shortness of breath | 2/40 (5%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
BTG can require Investigator to postpone publications/presentations for up to 12 months so data from all sites can be published. BTG will limit review of Investigator's draft to confirm Confidential Information is not being disclosed. If BTG notes publishing Study results may affect obtaining a patent, Investigator will not publish for up to 60 days until patent application is filed. Investigator will acknowledge BTG in any publication/presentation.
Results Point of Contact
Name/Title | Sr. Clinical Trial Specialist |
---|---|
Organization | Galil Medical, a wholly owned indirect subsidiary of Boston Scientific |
Phone | 651-287-5000 |
GalilClinical@bsci.com |
- CUC10-LNG06