Safety and Efficacy of Cryoablation for the Palliation of Painful Bone Metastases

Sponsor

Boston Scientific Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01461265

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

7.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain associated with metastatic bone tumors.

Condition or Disease	Intervention/Treatment	Phase
Pain Neoplasm Metastasis	Procedure: Cryoablation	Phase 1

Detailed Description

Patients with painful bone metastases who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy will be offered enrollment into the study. 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).

Patients agreeing to participate will read and sign an informed consent form and thus become subjects in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Subjects will be followed for up to 24 weeks (6 months) for palliation of pain, quality of life and analgesic usage. Baseline and follow-up data will be collected for each subject via a web-based electronic data collection tool.

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Cryoablation for the Palliation of Painful Bone Metastases

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Cryoablation All subjects will have cryoablation on one or two painful metastatic bone tumors.	Procedure: Cryoablation For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator. Other Names: Cryotherapy Cryosurgery Visual-ICE Cryoablation System SeedNet Cryoablation System PresIce Cryoablation System IceRod Cryoablation Needle IceRod PLUS Cryoablation Needle IceEDGE 2.4 Cryoablation Needle IceSeed Cryoablation Needle IceSphere Cryoablation Needle

Arm

Intervention/Treatment

Other: Cryoablation

All subjects will have cryoablation on one or two painful metastatic bone tumors.

Procedure: Cryoablation

For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator.

Other Names:

Cryotherapy

Cryosurgery

Visual-ICE Cryoablation System

SeedNet Cryoablation System

PresIce Cryoablation System

IceRod Cryoablation Needle

IceRod PLUS Cryoablation Needle

IceEDGE 2.4 Cryoablation Needle

IceSeed Cryoablation Needle

IceSphere Cryoablation Needle

Outcome Measures

Primary Outcome Measures

Difference in worst pain scores [24 weeks post-cryoablation]
The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale.

Secondary Outcome Measures

Cryoablation retreatments [24 weeks post-cryoablation]
If the first cryoablation procedure effectively relieves pain but the relief wears off over time and the pain becomes unbearable, a second procedure may be performed. The number of repeat cryoablation treatments will be recorded.
Additional surgical treatments other than cryoablation [24 weeks post-cryoablation]
If pain is not effectively relieved by the cryoablation, other surgical treatments may be performed. The number of these treatments will be recorded.
Reduced analgesic usage [24 weeks post-cryoablation]
The number of subjects (percentage) who are able to reduce analgesic medications from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation will be recorded.
Time to maximal palliation of pain after cryoablation [24 weeks post-cryoablation]
The difference in pain scores will be assessed from baseline to follow-up intervals after cryoablation will be analyzed. The interval indicating the most relief from pain will be compared across subjects.
Subject satisfaction with the amount palliation of pain obtained from cryoablation [24 weeks post-cryoablation]
Subject satisfaction will be compared at baseline to follow-up intervals.
Number of adverse events [30 days post-cryoablation]
The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure.
Difference in average pain scores [24 weeks post-cryoablation]
Difference in average pain scores from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation as measured on the numeric 0 to 10 BPI scale
Time to recurrence of worst pain [24 weks post-cryoablation]
Time to recurrence of worst pain at or above baseline; worst pain score in the 24 week follow-up period as measured on the numeric 0 to 10 BPI scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age or older
Metastatic bone disease with metastatic disease previously confirmed by prior biopsy; or Metastatic bone disease previously confirmed on imaging [e.g. computed tomography (CT) or magnetic resonance imaging (MRI)] with known (biopsied) primary disease (primary bone cancer is excluded)
Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
Unremitting pain that resulted in a return visit to the oncologist. The 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite pharmaceutical pain management
Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (additional less painful metastatic sites may be present)
Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, MRI, or ultrasound (US) imaging
Tumors must be suitable for cryoablation
Cryoablation should be performed within 14 days of baseline evaluations
Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3
Life expectancy ≥ 2 months
Platelet count >50,000/mm³ within 6 weeks screening
INR (International Normalized Ratio) <1.5 within 6 weeks screening
No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
Clinically suitable for cryoablation therapy

Exclusion Criteria:

Leukemia, lymphoma, and myeloma
Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
Has undergone prior ablation treatment of the index tumor
Prior radiation therapy of the index tumor <3 weeks prior to screening
Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
Anticipated treatment of the index tumor that would require iceball formation within 1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava, bowel, or bladder
Surgery at the tumor site or surgery involving the cryoablation-treated tumor (index tumor)
Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
Patient currently with neutropenia (absolute neutrophil count <1000) within 6 weeks screening
Uncontrolled coagulopathy or bleeding disorders
Currently pregnant, nursing, or wishing to become pregnant during the study
Active, uncontrolled infection
Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to study entry
Concurrent participation in other experimental studies that could affect the primary endpoint

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
2	University of Texas M.D. Anderson Cancer Center	Houston	Texas	United States	77030
3	University of British Columbia	Vancouver	British Columbia	Canada	V5Z 1L8
4	University Hospital of Strasbourg	Strasbourg		France	F-67091