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

Phase

N/A

Condition

Kidney Cancer

Renal Cell Cancer

Carcinoma

Treatment

13C-Glucose

13C-Fructose

13C-Lactate

Clinical Study ID

NCT04623502

STU-2019-1061

R35CA220449

P50CA196516

HHMI Investigator:DeBerardinis

F31CA239330

Ages > 18
All Genders
Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

Patients must have radiographic evidence of known or probable kidney or urothelialcancer 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 evaluatedon a case by case basis by the Principal Investigator, Dr. Vitaly Margulis, MD.

Exclusion

Exclusion Criteria:

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

Study Design

13C-Glucose

September 30, 2019

September 30, 2027

Study Description

The purpose of this study is to understand the metabolism of kidney cancers (renal cell carcinomas and urothelial cell carcinomas involving the kidney) in patients. Metabolism is the term used to describe how cells take up different nutrients and convert them to energy and materials needed for cell growth. In cancer, metabolism is hijacked to support the needs of cancer cells. Cancer cells can use multiple nutrients in the blood to fuel their growth, but it is not known what materials cancer cells make with those nutrients in patients.

Many participants in this study will be infused with a 13C-labeled nutrient during their surgery or biopsy. 13C means that the carbon in the nutrient is heavier than 12C carbons that are the most abundant carbon atoms in nature. 13C carbons account for about 1% of natural carbon atoms are not radioactive or harmful in any way. Using the tissue collected during or after surgery and/or biopsy, the researchers can track how the heavier 13C carbons from the infused nutrient are being used to make different materials that cancer cells need to grow.

The researchers hope to understand how kidney cancers change their metabolism to adapt, grow, and survive in patients. The knowledge learned from this study will be used to support the development of therapies that target metabolic adaptations, and the development of new non-invasive imaging techniques that will improve the care and survival of future kidney cancer patients.

Connect with a study center

University of Texas Southwestern Medical Center
Dallas, Texas 75390
United States
Site Not Available
University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286 75390
United States
Active - Recruiting

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