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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

HPCardiotox Trial 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.Check my eligibility
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.See study design
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.

HPCardiotox Trial 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.

HPCardiotox Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Detect subclinical anthracycline induced cardiotoxicity using hyperpolarized carbon-13 pyruvate

HPCardiotox 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
1,047 Previous Clinical Trials
1,053,689 Total Patients Enrolled
22 Trials studying Breast Cancer
6,262 Patients Enrolled for Breast Cancer
Vlad G Zaha, MD, PhDPrincipal InvestigatorAdvanced Imaging Research Center
1 Previous Clinical Trials
128 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for new volunteers to partake in this research endeavor?

"Unfortunately, clinicaltrials.gov states that this study is not looking to include any additional participants at present; the trial was initially listed on July 1st 2018 and last updated November 15th 2022. However, there are 2289 other studies in need of patients currently open for enrollment."

Answered by AI
~5 spots leftby Aug 2024