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New MRI technique aims to detect hidden heart harm from cancer radiation

NCT ID NCT04044872

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested whether a special MRI technique could detect early signs of heart damage caused by radiation therapy in people with thoracic or left-sided breast cancer. The approach used an injected substance (hyperpolarized pyruvate) to measure changes in heart cell energy use. Only 3 participants were enrolled before the study was terminated, so results are very limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hyperpolarized [1-13C]pyruvate
What this could lead to
If successful, this imaging technique could help doctors detect radiation-induced heart damage earlier, potentially guiding safer radiation plans.
What could go wrong
This was a very small, early feasibility study that was terminated before completion. The method is still experimental and may not prove useful in larger, more diverse groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

3 people

The number who actually took part.

Started

Dec 2019

Finished

Aug 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Benign or malignant tumor of the breast (left-sided only) or thorax 2. Stage I to IV. If stage IV, patient must have life expectancy equal to or greater than 6 months 3. ECOG performance status 0-1 4. The patient must be deemed an appropriate candidate for standard of care radiation therapy 5. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 5.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 5.2. A female of postmenopausal status is defined as patients over 60 or greater OR patients age 50-59 who meet the following criteria: * s/p bilateral oophorectomy, OR * with intact uterus without menses in the past 12 months OR, * with biochemical confirmation of post-menopausal status (estradiol in the menopausal range based on local laboratory criteria) 6. Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: 1. Prior radiation involving the heart 2. Subjects may not be receiving any known cardiotoxic agents for the 6 months prior to the study and during the study 3. Diagnosis of connective tissue disorders, including systemic lupus erythematosis, scleroderma, or dermatomyositis 4. Patients with stage IV cancer with life expectancy of less than 6 months 5. 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, in the opinion of the investigator, would limit compliance with study requirements 6. eGFR \<30 7. Any contraindication to MRI (including, but not limited to metal implants and devices contraindicated at 3T, breast tissue expanders, non-MR compatible IV port, claustrophobia) 8. History of psychiatric or addictive disorders that would preclude obtaining informed consent 9. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma Cardiotoxicity thoracic cancer Unilateral Breast Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Department of Radiation Oncology; UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.