Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title: Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

• NCT number: NCT02645409
• Study type: Interventional
• Source: Indiana University
• Status: Completed
• Phase: N/A
• Start date: December 29, 2015
• Completion date: April 2, 2019