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Metabolic Tracers for Kidney Cancer

N/A
Recruiting
Led By Vitaly Margulis, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have radiographic evidence of known or probable kidney or urothelial cancer requiring surgical biopsy or excision.
Age ≥ 18 years
Must not have
Uncontrolled or poorly controlled diabetes for patients receiving a 13C infusion
Not a surgical candidate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the metabolism of kidney cancers to see how they use fuel to grow. People with kidney cancer who are having surgery or a biopsy can participate.

Who is the study for?
Adults with probable or confirmed kidney or urothelial cancer needing surgery can join. They must understand and sign consent, and may be in other trials if approved by the lead doctor. Not for those with uncontrolled diabetes (if getting a tracer infusion), pregnant/breastfeeding women, or non-surgical candidates.
What is being tested?
The study is examining how kidney cancers metabolize different nutrients during surgery using labeled tracers like glucose and lactate. Participants will receive these through an IV to track tumor fuel use without affecting their standard treatment.
What are the potential side effects?
Since this trial involves observation of metabolism rather than testing new drugs, side effects are minimal but may include discomfort from IV placement and potential reactions to the nutrient tracers used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need a biopsy or surgery for my suspected kidney or bladder cancer.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My diabetes is not well-managed.
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I cannot have surgery for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of 13C isotopologue distributions

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: 13C-LactateExperimental Treatment1 Intervention
Group II: 13C-GlutamineExperimental Treatment1 Intervention
Group III: 13C-GlucoseExperimental Treatment1 Intervention
Group IV: 13C-FructoseExperimental Treatment1 Intervention
Group V: 13C-AcetateExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,089 Previous Clinical Trials
1,059,083 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,111,980 Total Patients Enrolled
Howard Hughes Medical InstituteOTHER
3 Previous Clinical Trials
23,902 Total Patients Enrolled
Vitaly Margulis, MDPrincipal Investigator - University of Texas Southwestern Medical Center
Children's Medical Center of Dallas, The University of Texas Southwestern Medical Center At Dallas, UT Southwestern Medical Center-Zale Lipshy Campus
University Of Texas Southwestern Medical Ctr At Dallas (Medical School)
U Tx-M D Anderson Cancer C (Residency)
2 Previous Clinical Trials
130 Total Patients Enrolled

Media Library

13C-Acetate Clinical Trial Eligibility Overview. Trial Name: NCT04623502 — N/A
Kidney Cancer Research Study Groups: 13C-Fructose, 13C-Lactate, 13C-Glucose, 13C-Acetate, 13C-Glutamine
Kidney Cancer Clinical Trial 2023: 13C-Acetate Highlights & Side Effects. Trial Name: NCT04623502 — N/A
13C-Acetate 2023 Treatment Timeline for Medical Study. Trial Name: NCT04623502 — N/A
~27 spots leftby Mar 2025
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