Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma

NCT ID: NCT02645409

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-29
• Study Completion Date: 2019-04-02

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Partial nephrectomy

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.

Group Type: EXPERIMENTAL

OTL38

Intervention Type: DRUG

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.

Intraoperative fluorescence imaging system

Intervention Type: DEVICE

Radical nephrectomy

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.

Group Type: EXPERIMENTAL

OTL38

Intervention Type: DRUG

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.

Intraoperative fluorescence imaging system

Intervention Type: DEVICE

Interventions

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.

Intervention Type: DRUG

Intraoperative fluorescence imaging system

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ≥ 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.

• ≥ 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chandru Sundaram

OTHER

Sponsor Role: lead

Responsible Party

Chandru Sundaram

Professor, Director of the Residency Program and Minimally Invasive Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Chandru P. Sundaram, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine, Indiana University Simon Cancer Center

Locations

Indiana University Health Hospital

Indianapolis, Indiana, United States

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IUSCC-0546

Identifier Type: -

Identifier Source: org_study_id