Kidney CancerNCT04623502
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
A study testing 13C-Glucose, 13C-Acetate and 13C-Lactate in people with Kidney Cancer and Renal Cell Carcinoma, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Cancer, Renal Cell Carcinoma, Clear Cell Carcinoma
- What is being tested?
- 13C-Glucose, 13C-Acetate and 13C-Lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Uncontrolled or poorly controlled diabetes for patients receiving a 13C infusion
- Pregnant or breastfeeding
- Not a surgical candidate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Vitaly Margulis, 214-648-0567, vitaly.margulis@utsouthwestern.edu
MD
About this study
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.
Read the detailed 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.
- Conditions
- Kidney Cancer, Renal Cell Carcinoma, Clear Cell Carcinoma, Urothelial Carcinoma, Metastatic Kidney Cancer, Metastatic Urothelial Carcinoma
- Being tested
- 13C-Glucose, 13C-Acetate, 13C-Lactate, 13C-Glutamine, 13C-Fructose
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell, Adenocarcinoma, Clear Cell, Carcinoma, Transitional Cell, Fumaric aciduria, Hereditary leiomyomatosis and renal cell cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C-GlucoseOther
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-AcetateOther
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-LactateOther
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-GlutamineOther
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-FructoseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 13C-Glucose | Experimental | Not described Receives: Other: 13C-Glucose |
| 13C-Acetate | Experimental | Not described Receives: Other: 13C-Acetate |
| 13C-Lactate | Experimental | Not described Receives: Other: 13C-Lactate |
| 13C-Glutamine | Experimental | Not described Receives: Other: 13C-Glutamine |
| 13C-Fructose | Experimental | Not described Receives: Other: 13C-Fructose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start30 Sep 2019
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Howard Hughes Medical Institute, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Vitaly Margulis, University of Texas Southwestern Medical Center
- Investigators
- Vitaly Margulis, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623502
- Sponsor's protocol ID
- STU-2019-1061
- Other IDs
- P50CA196516, R35CA220449, F31CA239330, HHMI Investigator:DeBerardinis
- Status last verified
- Jan 2026
- First submitted
- 19 Oct 2020
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No