Understanding Kidney and Urothelial Tumor Metabolism

This study aims to understand how kidney cancers, including renal cell carcinomas and urothelial cell carcinomas, use different nutrients to grow. Researchers will give participants an infusion of a specially labeled nutrient (13C-Glucose, 13C-Acetate, 13C-Lactate, 13C-Glutamine, or 13C-Fructose) for 2-3 hours before surgery or biopsy. These nutrients are common and not harmful. During the infusion, blood samples will be taken every 30 minutes. After surgery, a tissue sample will be collected. This allows researchers to track how cancer cells use these nutrients. The study is looking for 600 participants aged 18 or older with kidney or urothelial cancer needing surgery or biopsy. The main goal is to measure how these labeled nutrients are used by the cancer cells over 5 years.

Study design
This is an interventional study with a planned enrollment of 600 participants. It is not specified if it's randomized or blinded.
What's involved
You would receive an intravenous (IV) infusion of a labeled nutrient for 2-3 hours before surgery or biopsy. Blood samples will be collected approximately every 30 minutes during the infusion.
Compensation
Not stated in the trial record.
Follow-up
The study will measure the use of labeled nutrients by cancer cells for 5 years after the initial procedure.

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NCT04623502

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

Recruiting
NAAges 18+InterventionalBasic science
University of Texas Southwestern Medical Center
~600 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:13C-Glucose13C-Acetate13C-Lactate13C-Glutamine13C-Fructose

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of 13C isotopologue distributions
Measured over 5 years
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
1 sites across 1 states
Texas1
  • Vitaly Margulis, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

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Eligibility criteria

Inclusion

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.

Exclusion

Uncontrolled or poorly controlled diabetes for patients receiving a 13C infusion
Pregnant or breastfeeding
Not a surgical candidate
  • Percent of 13C isotopologue distributions5 years

    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.