An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy

NCT04623502 | Recruiting DMC

• 5 other identifiers: STU-2019-1061P50CA196516R35CA220449F31CA239330HHMI Investigator:DeBerardinis
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand the metabolism of cancers involving the kidney, including renal cell carcinomas and urothelial cell carcinomas, and how kidney cancers use different types of fuel to support tumor growth. This study uses specially labeled nutrient tracers of compounds normally found circulating in the blood. The nutrients (glucose, fructose, glutamine, acetate, and lactate) are also found in common foods. A nutrient tracer will be given to the participants through an intravenous (IV) catheter during surgery or biopsy, and blood will be collected every 30 minutes during the infusion to monitor safety parameters and the nutrient tracers. The investigators will collect a tissue sample after the completion of surgery. Participants not having an infusion will have their tissue collected after surgery or biopsy. Participation in this study will not change patient care. All patients will receive standard of care treatment as determined by their doctors.

Conditions

Kidney Cancer; Renal Cell Carcinoma; Clear Cell Carcinoma; Urothelial Carcinoma; Metastatic Kidney Cancer; Metastatic Urothelial Carcinoma; Papillary Renal Cell Carcinoma; HLRCC; Chromophobe Renal Cell Carcinoma; Fumarate Hydratase Deficiency; Succinate Dehydrogenase-Deficient Renal Cell Carcinoma; Hereditary Leiomyomatosis and Renal Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Percent of 13C isotopologue distributions

  Tissue and blood samples will be analyzed for 13C isotopologue distributions (percent) in central carbon metabolites using mass spectrometry. This allows the Investigators to understand how different subtypes of kidney and urothelial cancers alter utilization of the 13C tracers.

  5 years

Study Arms (5)

13C-Glucose

EXPERIMENTAL

Other: 13C-Glucose

13C-Acetate

EXPERIMENTAL

Other: 13C-Acetate

13C-Lactate

EXPERIMENTAL

Other: 13C-Lactate

13C-Glutamine

EXPERIMENTAL

Other: 13C-Glutamine

13C-Fructose

EXPERIMENTAL

Other: 13C-Fructose

Interventions

13C-Acetate OTHER

Patients in the 13C-acetate arm will receive an infusion of a 13C-acetate solution. In most cases, the acetate infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.

13C-Acetate

13C-Lactate OTHER

Patients in the 13C-lactate arm will receive an infusion of a 13C-lactate solution. In most cases, the lactate infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.

13C-Lactate

13C-Glutamine OTHER

Patients in the 13C-glutamine arm will receive an infusion of a 13C-glutamine solution. In most cases, the glutamine infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.

13C-Glutamine

13C-Fructose OTHER

Patients in the 13C-fructose arm will receive an infusion of a 13C-fructose solution. In most cases, the fructose infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.

13C-Fructose

13C-Glucose OTHER

Patients in the 13C-glucose arm will receive an infusion of a 13C-glucose solution. In most cases, the glucose infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.

13C-Glucose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have radiographic evidence of known or probable kidney or urothelial cancer requiring surgical biopsy or excision.
• Age ≥ 18 years
• Subjects of all races and ethnic origins
• The willingness to sign and ability to understand a written informed consent.
• Patients participating in other clinical trials are eligible, and will be evaluated on a case by case basis by the Principal Investigator, Dr. Vitaly Margulis, MD.

You may not qualify if:

• Uncontrolled or poorly controlled diabetes for patients receiving a 13C infusion
• Pregnant or breastfeeding
• Not a surgical candidate

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Howard Hughes Medical Institute: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell; Adenocarcinoma, Clear Cell; Carcinoma, Transitional Cell; Fumaric aciduria; Hereditary leiomyomatosis and renal cell cancer

Condition Hierarchy (Ancestors)

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

Study Officials

• Vitaly Margulis, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitaly Margulis, MD

CONTACT

214-648-0567; vitaly.margulis@utsouthwestern.edu

Ralph J DeBerardinis, MD, PhD

CONTACT

214-648-2585; ralph.deberardinis@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Urology

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: November 10, 2020
• Study Start: September 30, 2019
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

US (1)