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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2026
  • participants needed
    600
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 26 January 2021

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.

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.

Details
Condition Adenocarcinoma, urinary tract neoplasm, Malignant neoplasm of kidney, Nephropathy, Transitional cell carcinoma, Renal Cell Carcinoma, Clear cell adenocarcinoma, Kidney Disease (Pediatric), HLRCC, Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer, Hereditary Leiomyomatosis and Renal Cell Cancer, Metastatic Urothelial Carcinoma, Metastatic Kidney Cancer, Kidney Cancer, Malignant Adenoma, Kidney Disease, Renal Cell Cancer, Renal Cancer, Urologic Cancer, Succinate Dehydrogenase Deficient Renal Cell Carcinoma, Urothelial Carcinoma, clear cell renal cell carcinoma, clear cell carcinoma, cancer, renal, prcc, stage iv kidney cancer, papillary renal cell carcinoma, Fumarate Hydratase Deficiency
Treatment 13C-glucose, 13C-Acetate, 13C-Lactate, 13C-Glutamine, 13C-Fructose
Clinical Study IdentifierNCT04623502
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: clear cell renal cell carcinoma or Malignant neoplasm of kidney or Renal Cancer or Renal Cell Carcinoma or Clear cell adenocarcinoma or Stage IV Renal...?
Do you have any of these conditions: Transitional cell carcinoma or Nephropathy or Kidney Disease (Pediatric) or Kidney Cancer or stage iv kidney cancer or Kidney Disease or Fumarate Hydr...?
Do you have any of these conditions: Kidney Cancer or Metastatic Kidney Cancer or Succinate Dehydrogenase Deficient Renal Cell Carcinoma or Nephropathy or HLRCC or prcc or papillary renal...?
Do you have any of these conditions: Stage IV Renal Cell Cancer or Hereditary Leiomyomatosis and Renal Cell Cancer or papillary renal cell carcinoma or Fumarate Hydratase Deficiency or Re...?
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
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