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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 month before the radiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month before the radiation
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with a connective tissue disorder like lupus, scleroderma, or dermatomyositis.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.You have something in your body that can't be in the same room as a strong magnet, or you're very afraid of being in small, enclosed spaces.I have had radiation treatment that involved my heart.I am fully active or can carry out light work.My doctor expects I have less than 6 months to live due to stage IV cancer.I agree to use effective birth control or abstain from sex during and for 90 days after the study.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.I haven't taken any heart-damaging medications in the last 6 months.Your kidney function is very low, with an estimated glomerular filtration rate (eGFR) less than 30.I am considered suitable for standard radiation treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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