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

Introduction

• Org Study ID: STU2019-1061
• NTC ID: NCT04623502
• Lead Sponsor Name: University of Texas Southwestern Medical Center
• Status: RECRUITING

Conditions

• Chromophobe Renal Cell Carcinoma
• Clear Cell Renal Cell Carcinoma
• Collecting Duct Renal Cell Carcinoma
• Hereditary Leiomyomatosis and Renal Cell Carcinoma
• Papillary Renal Cell Carcinoma
• Renal Medullary Carcinoma
• Succinate Dehydrogenase-Deficient Renal Cell Carcinoma
• Translocation/TFE Renal Cell Carcinoma
• Unclassified Renal Cell Carcinoma

Brief Summary

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.

Eligibility 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