Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

Official title:

Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02645409
• Other study ID #: IUSCC-0546
• Status: Completed
• Phase: N/A
• Start date: December 29, 2015
• Est. completion date: April 2, 2019

Study information

• Verified date: February 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2, 2019
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Drug:
• OTL38
OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.

Device:
• Intraoperative fluorescence imaging system

Locations

Country	Name	City	State
United States	Indiana University Health Hospital	Indianapolis	Indiana
United States	Indiana University Health Melvin and Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Chandru Sundaram

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Presence of Fluorescence of cT1 RCC in Partial Nephrectomy Specimens	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.	During procedure, an average of 2 hours