Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma

Not Applicable

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: OTL38; Device: Intraoperative fluorescence imaging system

• Registration Number: NCT02645409
• Lead Sponsor: Chandru Sundaram

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.

Study Timeline

• Study First Submitted: 2015-12-08
• Study Start: 2015-12-29
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2016-01-01
• Primary Completion: 2018-03-20
• Study Completion: 2019-04-02
• Results First Submitted: 2019-08-21
• Results First Submitted QC: 2019-12-19
• Results First Posted: 2020-01-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-16
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partial nephrectomy	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 partial nephrectomy. Photographs of the surgery field and tumor (ex-vivo) will be taken under normal light and fluorescent light.
Radical nephrectomy	OTL38	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.
Radical nephrectomy	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.
Partial nephrectomy	OTL38	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Indiana University Health Melvin and Bren Simon Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Indiana University Health Hospital; 🇺🇸 Indianapolis, Indiana, United States