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

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT04623502

Run by

University of Texas Southwestern Medical Center

People needed

600

Starts

2019-09-30

Expected to finish

2027-09-30

Last updated by the study team

2026-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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