79 Participants Needed

Hyperpolarized 13C-Pyruvate Imaging for Chemotherapy-Related Heart Damage

(HPCardiotox Trial)

Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The anthracycline doxorubicin, first introduced in the 1960's, continues to be an effectively utilized antineoplastic drug. Even at relatively low cumulative doses there is risk of cardiotoxicity. However, the incidence of subclinical cardiotoxicity is not known, carrying a potential risk for late effects in cancer survivors. Doxorubicin has systemic toxicity that may contribute to cardiac metabolic stress, but the main cardiotoxic mechanism involves cardiac mitochondria. The primary goal of this study is to detect early changes in the mitochondrial metabolism in situ as a marker for subclinical doxorubicin induced cardiotoxicity. The problem of cardiovascular complications following chemotherapy for breast cancer goes far beyond anthracyclines alone. In addition, other agents such as trastuzumab, and pertuzumab and emerging novel therapies may also promote cardiovascular injury. The secondary objective is to test the hypothesis that cardiotoxicity due to other medical anticancer therapies and radiation therapy involving the heart field is associated with a signature of early impaired aerobic cardiac metabolism through pyruvate dehydrogenase.

Research Team

VG

Vlad G Zaha, MD, PhD

Principal Investigator

Advanced Imaging Research Center

Eligibility Criteria

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.

Inclusion Criteria

My treatment plan includes drugs that may affect my heart.
Patients for the formal study should not have started the cardiotoxic therapy yet
I am a male and either surgically sterile or my partner uses birth control.
See 5 more

Exclusion Criteria

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
My cancer has spread to distant parts of my body.
I have been diagnosed with diabetes.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline MRI

Participants undergo a baseline cardiac MRI scan before administration of cardiotoxic therapy

1 day
1 visit (in-person)

Cardiotoxic Therapy

Participants receive cardiotoxic therapy as part of their standard cancer treatment

Varies based on individual treatment plans

Post-Therapy MRI

Participants undergo a cardiac MRI scan after completion of cardiotoxic therapy

1 day
1 visit (in-person)

Follow-up MRI

Participants undergo a follow-up cardiac MRI scan 1 to 6 months after the first post-therapy MRI

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Treatment Details

Interventions

  • Hyperpolarized [1-13C]Pyruvate
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+
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