Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2019-04-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chandru Sundaram
• Treatments: Folic Acid

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