Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
Study Details
Study Description
Brief Summary
Primary
• To explore the use of OTL38 and fluorescence imaging to detect RCC in partial nephrectomy at the margins of resection, and in lymph node(s) or other metastases during radical nephrectomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Administration of the study drug, OTL38, will begin prior to skin incision in the preoperative area where safety monitoring will occur. The tumor resection occurs approximately 2 hours after being brought back to the operating room and so there is no wait time between infusion and being taken back to operating room. Intraoperative fluorescent imaging will be utilized in parallel with the standard operating procedure to capture images during surgery. Images also will be taken of the excised specimen on the back table. The excised specimen will be sent to the pathology department for fluorescent imaging and immunohistochemistry for FR. Subjects will have a 2-5 day hospital stay (normal nephrectomy recovery period) where safety measurements will be taken. Final safety measurements will be taken at the 10-day and 1-month follow-up visits.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Partial nephrectomy OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light. |
Drug: OTL38
OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.
Device: Intraoperative fluorescence imaging system
|
| Experimental: Radical nephrectomy OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for radical nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light. |
Drug: OTL38
OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.
Device: Intraoperative fluorescence imaging system
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Presence of Fluorescence of cT1 RCC in Partial Nephrectomy Specimens [During procedure, an average of 2 hours]
Pathology results will be compared with immunohistochemistry results for each patient. Fluorescence will be looked for in the margins of resection for partial nephectomy and in regional lymph nodes and metastases for radical nephrectomy.
Eligibility Criteria
Criteria
Inclusion criteria for localized RCC treated with partial nephrectomy
To be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below:
-
≥ 18 years of age.
-
Have primary or suspected diagnosis of RCC, with presence of cT1-2 renal mass by diagnostic CT assessment.
-
Scheduled for partial nephrectomy of renal mass.
-
Expected survival of at least 3 months.
-
Written informed consent available.
-
ECOG ≤ 1 (Appendix G).
-
Negative serum or urine pregnancy test within 24 hours for females of child bearing age
-
Recovered from toxicity of any prior therapy to ≥ grade 1.
Inclusion criteria for advanced RCC treated with radical nephrectomy
To be considered eligible to participate in this study, a patient must meet all the inclusion criteria listed below:
-
≥ 18 years of age.
-
Have pathologic or suspected diagnosis of RCC with presence of cT1-4 renal mass and evidence of nodal or metastatic involvement by diagnostic CT assessment
-
Scheduled for radical nephrectomy and lymph node dissection.
-
Expected survival of at least 3 months.
-
ECOG ≤ 2.
-
Negative serum or urine pregnancy test within 24 hours for females of child bearing age.
-
Recovered from toxicity of any prior therapy to ≥ grade 1
-
Written informed consent available.
Exclusion criteria for both localized and advanced RCC
-
History of any anaphylactic reaction, any severe allergy, or any allergy to folate.
-
Brain metastases
-
Baseline GFR < 50 mL/min/1.73m2)
-
Hepatic toxicity ≥ Grade 2 (using CTCAE version 4 standard definitions).
-
Participation in another investigational drug trial either concurrently or 30 days prior to surgery
-
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient, limit the patient's ability to complete the study, and/or compromise the objectives of the study.
-
Known sensitivity to fluorescent light
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University Health Hospital | Indianapolis | Indiana | United States | 46202 |
| 2 | Indiana University Health Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Chandru Sundaram
Investigators
- Principal Investigator: Chandru P. Sundaram, MD, Indiana University School of Medicine, Indiana University Simon Cancer Center
Study Documents (Full-Text)
More Information
Publications
None provided.- IUSCC-0546
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Partial Nephrectomy | Radical Nephrectomy |
|---|---|---|
| Arm/Group Description | OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light. OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma. Intraoperative fluorescence imaging system | OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for radical nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light. |
| Period Title: Overall Study | ||
| STARTED | 14 | 0 |
| COMPLETED | 10 | 0 |
| NOT COMPLETED | 4 | 0 |
Baseline Characteristics
| Arm/Group Title | Partial Nephrectomy | Radical Nephrectomy | Total |
|---|---|---|---|
| Arm/Group Description | OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light. OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma. Intraoperative fluorescence imaging system | OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for radical nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light. OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma. | Total of all reporting groups |
| Overall Participants | 10 | 0 | 10 |
| Age, Customized (Count of Participants) | |||
| 50-70 |
10
100%
|
10
Infinity
|
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
1
10%
|
1
Infinity
|
|
| Male |
9
90%
|
9
Infinity
|
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
NaN
|
|
| Asian |
0
0%
|
0
NaN
|
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
NaN
|
|
| Black or African American |
0
0%
|
0
NaN
|
|
| White |
10
100%
|
10
Infinity
|
|
| More than one race |
0
0%
|
0
NaN
|
|
| Unknown or Not Reported |
0
0%
|
0
NaN
|
|
| Region of Enrollment (participants) [Number] | |||
| United States |
10
100%
|
10
Infinity
|
|
| BMI (kg/m^2) [Mean (Full Range) ] | |||
| Mean (Full Range) [kg/m^2] |
29.4
|
29.4
|
|
| Pathologic Tumor Stage (Count of Participants) | |||
| pT1a |
8
80%
|
8
Infinity
|
|
| pT3a |
1
10%
|
1
Infinity
|
|
| Benign |
1
10%
|
1
Infinity
|
|
| Negative Post-Surgical Margins (Count of Participants) | |||
| Count of Participants [Participants] |
10
100%
|
10
Infinity
|
|
Outcome Measures
| Title | Number of Participants With Presence of Fluorescence of cT1 RCC in Partial Nephrectomy Specimens |
|---|---|
| Description | Pathology results will be compared with immunohistochemistry results for each patient. Fluorescence will be looked for in the margins of resection for partial nephectomy and in regional lymph nodes and metastases for radical nephrectomy. |
| Time Frame | During procedure, an average of 2 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Partial Nephrectomy |
|---|---|
| Arm/Group Description | OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light. OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma. Intraoperative fluorescence imaging system |
| Measure Participants | 10 |
| Count of Participants [Participants] |
10
100%
|
Adverse Events
| Time Frame | 30 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | There are zero participants at risk in the radical nephrectomy arm because no patients enrolled in this arm | |||
| Arm/Group Title | Partial Nephrectomy | Radical Nephrectomy | ||
| Arm/Group Description | OTL38 will be given approximately 2 hours before surgery. Intraoperative fluorescent imaging will utilized in parallel with standard operating procedures for partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light. OTL38: OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma. Intraoperative fluorescence imaging system | OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma. OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma | ||
All Cause Mortality |
||||
| Partial Nephrectomy | Radical Nephrectomy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/0 (NaN) | ||
Serious Adverse Events |
||||
| Partial Nephrectomy | Radical Nephrectomy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/0 (NaN) | ||
Other (Not Including Serious) Adverse Events |
||||
| Partial Nephrectomy | Radical Nephrectomy | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/10 (10%) | 0/0 (NaN) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| hypoxia | 1/10 (10%) | 1 | 1/0 (Infinity) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Courtney Dhondt, Clinical Research Nurse |
|---|---|
| Organization | Indiana University |
| Phone | 317-274-1791 |
| cgerler@iu.edu |
- IUSCC-0546