Brief Title
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
Official Title
An Investigation of Kidney and Urothelial Tumor Metabolism in Patients Undergoing Surgical Resection and/or Biopsy
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.
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.
Study Type
Interventional
Primary Outcome
Percent of 13C isotopologue distributions
Condition
Kidney Cancer
Intervention
13C-Glucose
Study Arms / Comparison Groups
13C-Glucose
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
600
Start Date
September 30, 2019
Completion Date
September 30, 2026
Primary Completion Date
September 30, 2024
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Vitaly Margulis, MD, 214-648-0567, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04623502
Organization ID
STU2019-1061
Secondary IDs
P50CA196516
Responsible Party
Principal Investigator
Study Sponsor
University of Texas Southwestern Medical Center
Collaborators
Howard Hughes Medical Institute
Study Sponsor
Vitaly Margulis, MD, Principal Investigator, University of Texas Southwestern Medical Center
Verification Date
December 2022