🏛️ Verified NIH Record • Updated 2026-01-27

An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy (NCT04623502)

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: University of Texas Southwestern Medical Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (4 items).

Location: University of Texas Southwestern Medical Center — Dallas, Texas

Age range: 18 Years

🧪 Interventions in This Study

  • 13C-Glucose (OTHER)
  • 13C-Acetate (OTHER)
  • 13C-Lactate (OTHER)
  • 13C-Glutamine (OTHER)
  • 13C-Fructose (OTHER)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • University of Texas Southwestern Medical Center — Dallas, Texas

📞 Contact the Study Coordinator

Phone: (214) 648-0567

Email: vitaly.margulis@utsouthwestern.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
  • 💵 Compensation indicated: All patients will receive standard of care treatment as determined by their doctors.

Explore by condition: All Kidney Cancer clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗