Hyperpolarized 13C-Pyruvate Imaging for Chemotherapy-Related Heart Damage
(HPCardiotox Trial)
What You Need to Know Before You Apply
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.
Who Is on the Research Team?
Vlad G Zaha, MD, PhD
Principal Investigator
Advanced Imaging Research Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline MRI
Participants undergo a baseline cardiac MRI scan before administration of cardiotoxic therapy
Cardiotoxic Therapy
Participants receive cardiotoxic therapy as part of their standard cancer treatment
Post-Therapy MRI
Participants undergo a cardiac MRI scan after completion of cardiotoxic therapy
Follow-up MRI
Participants undergo a follow-up cardiac MRI scan 1 to 6 months after the first post-therapy MRI
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Hyperpolarized [1-13C]Pyruvate
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor