Back to resultsIntraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
Primary Purpose
Renal Cell Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OTL38
Intraoperative fluorescence imaging system
Sponsored by
About this trial
This is an interventional treatment trial for Renal Cell Carcinoma focused on measuring Fluorescence, Imaging, Partial nephrectomy, Radical nephrectomy
Eligibility 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
Sites / Locations
- Indiana University Health Hospital
- Indiana University Health Melvin and Bren Simon Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Partial nephrectomy
Radical nephrectomy
Arm 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 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.
Outcomes
Primary Outcome Measures
Number of Participants With Presence of Fluorescence of cT1 RCC in Partial Nephrectomy Specimens
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02645409
Brief Title
Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
Official Title
Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 29, 2015 (Actual)
Primary Completion Date
March 20, 2018 (Actual)
Study Completion Date
April 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chandru Sundaram
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
Fluorescence, Imaging, Partial nephrectomy, Radical nephrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Partial nephrectomy
Arm Type
Experimental
Arm 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.
Arm Title
Radical nephrectomy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
OTL38
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Intraoperative fluorescence imaging system
Primary Outcome Measure Information:
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chandru P. Sundaram, MD
Organizational Affiliation
Indiana University School of Medicine, Indiana University Simon Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Health Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana University Health Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
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