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Metabolic Imaging Agent

Metabolic Imaging for Detecting Heart Damage After Radiation in Breast Cancer Patients

Phase < 1
Waitlist Available
Led By Prasanna Alluri, MD, PhD
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
ECOG performance status 0-1
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month before the radiation
Awards & highlights

Study Summary

This trial will study whether changes in the way the heart's mitochondria metabolize energy may be early markers for subclinical, radiation-induced cardiotoxicity.

Who is the study for?
This trial is for individuals with left-sided breast or thoracic tumors, stages I-IV, who are expected to live at least 6 months and can undergo standard radiation therapy. They must be able to perform daily activities (ECOG status 0-1), use contraception if of childbearing potential, and provide informed consent. Excluded are those with life expectancy under 6 months, prior heart radiation, taking cardiotoxic drugs within the last 6 months, severe illnesses or conditions that affect MRI safety.Check my eligibility
What is being tested?
[1-13C]pyruvate used in conjunction with MRI imaging aims to detect early mitochondrial changes in the heart as a marker for subclinical damage from radiation therapy in patients receiving standard care for breast or thoracic cancer. The study focuses on identifying cardiac injury before symptoms appear by monitoring metabolic shifts caused by treatment.See study design
What are the potential side effects?
While this trial primarily uses diagnostic tools rather than therapeutic interventions, risks may include typical MRI-related discomforts such as claustrophobia and loud noises during scanning. The contrast agent [1-13C]pyruvate's side effects aren't detailed but could potentially include reactions at the injection site or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I agree to use effective birth control or abstain from sex during and for 90 days after the study.
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My breast or thorax tumor is on the left side, and if it's stage IV, I am expected to live 6 months or more.
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I am considered suitable for standard radiation treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month before the radiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month before the radiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine if radiation-induced cardiac injury causes myocardial mitochondrial dysfunction
Secondary outcome measures
Determination of the prognostic value decreased of myocardial mitochondrial pyruvate flux in predicting clinically significant radiation induced cardiotoxicity.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Arm:Diagnosing Cardiotoxicity when on Radiation therapyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,039 Previous Clinical Trials
1,048,089 Total Patients Enrolled
Prasanna Alluri, MD, PhDPrincipal Investigator - UTSW Radiation Oncology
University of Texas Southwestern Medical Center

Media Library

[1-13C]pyruvate along with MRI imaging (Metabolic Imaging Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04044872 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Dec 2025