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

ConditionsKidney Cancer Renal Cell Carcinoma Clear Cell Carcinoma Urothelial Carcinoma Metastatic Kidney Cancer Metastatic Urothelial Carcinoma Papillary Renal Cell Carcinoma Chromophobe Renal Cell Carcinoma Fumarate Hydratase Deficiency Succinate Dehydrogenase-Deficient Renal Cell Carcinoma HLRCC Hereditary Leiomyomatosis and Renal Cell Cancer

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Texas Southwestern Medical Center

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Uncontrolled or poorly controlled diabetes for patients receiving a 13C infusion

Pregnant or breastfeeding

Not a surgical candidate

Trial design

Design model

Parallel

Treatments tested in this trial

13C-Glucose
Other intervention
Patients in the 13C-glucose arm will receive an infusion of a 13C-glucose solution. In most cases, the glucose infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.
13C-Acetate
Other intervention
Patients in the 13C-acetate arm will receive an infusion of a 13C-acetate solution. In most cases, the acetate infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.
13C-Lactate
Other intervention
Patients in the 13C-lactate arm will receive an infusion of a 13C-lactate solution. In most cases, the lactate infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.
13C-Glutamine
Other intervention
Patients in the 13C-glutamine arm will receive an infusion of a 13C-glutamine solution. In most cases, the glutamine infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.
13C-Fructose
Other intervention
Patients in the 13C-fructose arm will receive an infusion of a 13C-fructose solution. In most cases, the fructose infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.

Treatment groups

600 Participants

are divided into 5 treatment groups

Group A: 13C-GlucoseExperimental treatment 1 intervention

Group B: 13C-AcetateExperimental treatment 1 intervention

Group C: 13C-LactateExperimental treatment 1 intervention

Group D: 13C-GlutamineExperimental treatment 1 intervention

Group E: 13C-FructoseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Percent of 13C isotopologue distributions

Tissue and blood samples will be analyzed for 13C isotopologue distributions (percent) in central carbon metabolites using mass spectrometry. This allows the Investigators to understand how different subtypes of kidney and urothelial cancers alter utilization of the 13C tracers.

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

Howard Hughes Medical Institute

Collaborator

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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