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

Primary Purpose

Kidney Cancer, Renal Cell Carcinoma, Clear Cell Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
13C-Glucose
13C-Acetate
13C-Lactate
13C-Glutamine
13C-Fructose
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Kidney Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Texas Southwestern Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

13C-Glucose

13C-Acetate

13C-Lactate

13C-Glutamine

13C-Fructose

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 19, 2020
Last Updated
December 1, 2022
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Howard Hughes Medical Institute, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04623502
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Howard Hughes Medical Institute, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney 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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
13C-Glucose
Arm Type
Experimental
Arm Title
13C-Acetate
Arm Type
Experimental
Arm Title
13C-Lactate
Arm Type
Experimental
Arm Title
13C-Glutamine
Arm Type
Experimental
Arm Title
13C-Fructose
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
13C-Glucose
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
13C-Acetate
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
13C-Lactate
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
13C-Glutamine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
13C-Fructose
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of 13C isotopologue distributions
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vitaly Margulis, MD
Phone
214-648-0567
Email
vitaly.margulis@utsouthwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ralph J DeBerardinis, MD, PhD
Phone
214-648-2585
Email
ralph.deberardinis@utsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vitaly Margulis, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vitaly Margulis
Phone
214-648-0567
Email
vitaly.margulis@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
MD

12. IPD Sharing Statement

Learn more about this trial

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

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