Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma

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.

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