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

University of Texas Southwestern Medical Center · with Howard Hughes Medical Institute, National Cancer Institute (NCI) · NCT04623502

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
600
US sites recruiting
1
Study start
September 30, 2019
Record last updated
January 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: 13C-Glucose; 13C-Acetate; 13C-Lactate; 13C-Glutamine; 13C-Fructose

Conditions: 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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

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

Recruiting US locations

  • University of Texas Southwestern Medical Center

    Dallas, TX 75390

    Site contact: Vitaly Margulis · 214-648-0567 · vitaly.margulis@utsouthwestern.edu

Study contacts (from the official record)

  • Vitaly Margulis, MD · 214-648-0567 · vitaly.margulis@utsouthwestern.edu
  • Ralph J DeBerardinis, MD, PhD · 214-648-2585 · ralph.deberardinis@utsouthwestern.edu
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An Investigation of Kidney and Urothelial Tumor Metabolism in… (NCT04623502) | Bored Studies