Understanding how kidney tumors use nutrients for growth
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
NA · University of Texas Southwestern Medical Center · NCT04623502
This study tests how kidney tumors use certain nutrients to grow by giving participants a special nutrient infusion during surgery and checking their blood and tissue samples.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT04623502 on ClinicalTrials.gov |
What this trial studies
This study investigates the metabolism of kidney cancers, including renal cell and urothelial carcinomas, by using specially labeled nutrient tracers during surgical procedures. Participants will receive an infusion of 13C-labeled nutrients, and blood samples will be collected to monitor safety and nutrient utilization. Tissue samples will also be collected to analyze how cancer cells use these nutrients for growth. The findings aim to enhance understanding of cancer metabolism and support the development of targeted therapies and non-invasive imaging techniques.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed kidney or urothelial cancer who require surgical intervention.
Not a fit: Patients who are not surgical candidates or have uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to new therapies that specifically target the metabolic adaptations of kidney cancer cells, improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding cancer metabolism, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Vitaly Margulis, MD — University of Texas Southwestern Medical Center
- Study coordinator: Vitaly Margulis, MD
- Email: vitaly.margulis@utsouthwestern.edu
- Phone: 214-648-0567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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