Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT04623502

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

Led by University of Texas Southwestern Medical Center · Updated on 2026-01-28

600

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

Sponsors

U

University of Texas Southwestern Medical Center

Lead Sponsor

H

Howard Hughes Medical Institute

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have radiographic evidence of known or probable kidney or urothelial cancer requiring surgical biopsy or excision.
  • Age 18 years or older
  • Subjects of all races and ethnic origins
  • Willingness and ability to sign a written informed consent
  • Patients in other clinical trials may be eligible and will be evaluated individually by the Principal Investigator
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

V

Vitaly Margulis, MD

CONTACT

R

Ralph J DeBerardinis, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

5

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