Actively Recruiting
Investigation of Kidney and Urothelial Tumor Metabolism Using 13C-Labeled Nutrient Infusions During Surgical Biopsy or Resection
Led by University of Texas Southwestern Medical Center · Updated on 2026-01-28
600
Participants Needed
1
Research Sites
21 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
Researchers are investigating how kidney cancers, including renal cell carcinomas and urothelial cell carcinomas, use different nutrients to support tumor growth. The study aims to understand how these cancers metabolize various nutrients found in the blood and common foods. This knowledge may help develop new treatments targeting cancer metabolism and improve imaging techniques for kidney cancer care. Participants may receive an intravenous infusion of a specially labeled nutrient tracer, such as 13C-glucose, 13C-acetate, 13C-lactate, 13C-glutamine, or 13C-fructose, during surgery or biopsy. The infusion typically lasts 2 to 3 hours before tumor removal. Blood samples will be collected every 30 minutes during the infusion to monitor safety and track nutrient use by the tumor. Some participants will have tissue collected without infusion after surgery or biopsy. During the study, participants will undergo standard surgical procedures for their cancer without changes to their usual care. Researchers will collect tissue samples during or after surgery or biopsy to analyze how cancer cells use the infused nutrients. Blood tests will be done regularly during infusion to monitor glucose levels and blood acidity. The main outcome measured is the distribution of the labeled nutrient in the cancer tissue over five years. Participation duration varies depending on surgery timing and follow-up needs.
CONDITIONS
Brief Title
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
Who Can Participate
Eligibility Criteria
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
- Willing and able to sign and understand written informed consent
- Patients participating in other clinical trials are eligible and will be evaluated individually by the Principal Investigator
You will not qualify if you...
- Uncontrolled or poorly controlled diabetes in patients receiving a 13C infusion
- Pregnant or breastfeeding
- Not a surgical candidate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 3 hours
Participants receive an infusion of a 13C-labeled nutrient for 2 to 3 hours prior to surgical biopsy or resection of the tumor. During surgery, blood samples are taken approximately every 30 minutes to monitor blood glucose and pH. The infusion stops after tumor resection.
1 surgical procedure visit with blood sampling during surgery
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
V
Vitaly Margulis, MD
R
Ralph J DeBerardinis, MD, PhD
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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