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Metabolic Imaging Agent

Hyperpolarized 13C-Pyruvate Imaging for Chemotherapy-Related Heart Damage (HPCardiotox Trial)

Phase < 1
Waitlist Available
Led By Vlad G Zaha, 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
Plan for treatment as cardiotoxic therapy
Age ≥ 18 years
Must not have
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Subjects with known remote, macro, metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking for early changes in heart cells that may be caused by the chemotherapy drug doxorubicin.

Who is the study for?
This trial is for adults with breast cancer who haven't started or have already completed cardiotoxic therapy. They must be able to use contraception, not have diabetes, metal implants incompatible with MRI, or severe illnesses that could affect study participation. Pregnant women and those with certain blood disorders are excluded.
What is being tested?
The study aims to detect early signs of heart damage from the chemotherapy drug doxorubicin by using a special type of imaging after injecting hyperpolarized 13C-pyruvate. It will look at changes in heart metabolism as indicators of potential harm from this and similar treatments.
What are the potential side effects?
Potential side effects may include reactions related to the injection such as discomfort or bruising at the injection site, allergic reactions to components of the injected substance, and risks associated with MRI scans like discomfort due to claustrophobia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My treatment plan includes drugs that may affect my heart.
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I am 18 years old or older.
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I am a male and either surgically sterile or my partner uses birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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My cancer has spread to distant parts of my body.
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I have been diagnosed with diabetes.
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I do not have metal implants, am not pregnant, and do not have sickle cell disease or hemolytic anemia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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
Detect subclinical anthracycline induced cardiotoxicity using hyperpolarized carbon-13 pyruvate

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Formal StudyExperimental Treatment1 Intervention
Hyperpolarized 13C-pyruvate, is injected into patients before receiving cardiotoxic therapy and immediately after, for a cardiac MRI scan
Group II: Feasibility StudyExperimental Treatment1 Intervention
Hyperpolarized 13C-pyruvate injection, is given to patients after completing cardiotoxic therapy, and again at 1 to 6 six months after the first cardiac MRI scan

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,086 Previous Clinical Trials
1,058,552 Total Patients Enrolled
23 Trials studying Breast Cancer
6,264 Patients Enrolled for Breast Cancer
Vlad G Zaha, MD, PhDPrincipal InvestigatorAdvanced Imaging Research Center
1 Previous Clinical Trials
128 Total Patients Enrolled
~1 spots leftby Feb 2025