← Back to Search

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

Select...

My treatment plan includes drugs that may affect my heart.

Select...

I am 18 years old or older.

Select...

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:

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Select...

My cancer has spread to distant parts of my body.

Select...

I have been diagnosed with diabetes.

Select...

I do not have metal implants, am not pregnant, and do not have sickle cell disease or hemolytic anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

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

0 / 7Eligibility criteria met