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Brief Title: Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
Official Title: Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
Study ID: NCT02645409
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Indiana University Health Hospital, Indianapolis, Indiana, United States
Indiana University Health Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Name: Chandru P. Sundaram, MD
Affiliation: Indiana University School of Medicine, Indiana University Simon Cancer Center
Role: PRINCIPAL_INVESTIGATOR