Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma

NCT02645409 | Completed Results DMC

• 1 other identifier: IUSCC-0546
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Renal Cell Carcinoma

Keywords

Fluorescence; Imaging; Partial nephrectomy; Radical nephrectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Partial nephrectomy

EXPERIMENTAL

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.

Drug: OTL38; Device: Intraoperative fluorescence imaging system

Radical nephrectomy

EXPERIMENTAL

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.

Drug: OTL38; Device: Intraoperative fluorescence imaging system

Interventions

OTL38 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.

Partial nephrectomy; Radical nephrectomy

Intraoperative fluorescence imaging system DEVICE

Partial nephrectomy; Radical nephrectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chandru Sundaram: lead

Study Sites (2)

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Pafolacianine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Courtney Dhondt, Clinical Research Nurse
• Organization: Indiana University

cgerler@iu.edu

317-274-1791

Study Officials

• Chandru P. Sundaram, MD

  Indiana University School of Medicine, Indiana University Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Director of the Residency Program and Minimally Invasive Surgery

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: January 1, 2016
• Study Start: December 29, 2015
• Primary Completion: March 20, 2018
• Study Completion: April 2, 2019
• Last Updated: February 25, 2020
• Results First Posted: January 7, 2020

Record last verified: 2020-02

Locations

US (2)