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Cardiac magnetic resonance imaging and Echocardiogram to investigate myocardial structural and functional changes in patients undergoing irradiation for left sided breast cancer with or without Deep Inspiration Breath Hold

Cardiac magnetic resonance imaging and Echocardiogram to investigate myocardial structural and functional changes in patients undergoing irradiation for left sided breast cancer with or without Deep Inspiration Breath Hold

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001303235
Acronym
None
Enrollment
30
Registered
2018-08-02
Start date
2018-09-15
Completion date
2021-01-01
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to evaluate newer methods of investigating cardiac structure (specifically cardiac MRI T1 mapping sequences) and function (using echocardiogram measurements) in participants undergoing radiation therapy for left sided breast cancer. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with left sided breast cancer requiring radiation therapy. Study details. All participants will complete two cardiac MRI scans and two echocardiograms. The first MRI scan and echocardiogram will be done prior to the commencement of radiation therapy and the second scan and echocardiogram will be done six months after the completion of radiation therapy. It is hoped that this research will determine whether these tests are effective in determining changes in the structure and function of the heart at an early, potentially reversible stage in women undergoing treatment for left sided breast cancer.

Interventions

A Cardiac MRI using T1 mapping sequences to assess myocardial structural changes and a Echocardiogram using global strain imaging to assess myocardial functional changes will be performed in women undergoing radiation therapy to the left breast, or left chest wall +/- regional nodal areas with or without deep inspiration breath hold following surgery for left sided breast cancer. The MRI and echocardiogram will be performed between one to three weeks prior to commencement of radiation therap

A Cardiac MRI using T1 mapping sequences to assess myocardial structural changes and a Echocardiogram using global strain imaging to assess myocardial functional changes will be performed in women undergoing radiation therapy to the left breast, or left chest wall +/- regional nodal areas with or without deep inspiration breath hold following surgery for left sided breast cancer. The MRI and echocardiogram will be performed between one to three weeks prior to commencement of radiation therapy (baseline) and at six months post completion of radiation therapy. The cardiac MRI will take between 45 and 60 minutes and will be performed by a cardiac MRI technician. The images will be reviewed by a Cardiologist with a special interest in cardiac MRI. Deep inspiration breath hold (DIBH) is the process whereby the patient's breathing is monitored and, at a preset lung volume during inspiration, airflow is stopped for a short period of time, during which the radiation therapy is delivered. The duration of the breath hold and volume held is determined individually depending on what is comfortable for each patient. At the Princess Alexandra Hospital, the Elekta active breathing control (ABC) device has been used successfully for eighteen months. By holding the patient in deep inspiration, the lung expands, moving the heart away from the chest wall while the radiation beam is delivered, thus decreasing heart exposure to radiation. DIBH is monitored by the radiation therapists who are delivering the radiation treatment. The DIBH technique is offered to all women undergoing radiation therapy for left sided breast cancer. However, some women (less than 5%) are not able to comply with this technique and therefore do not undergo DIBH. These women are being offered participation in the cardiac MRI/Echocardiogram trial to determine if there is any difference between women who are able to undergo DIBH and those who do not in the incidence of cardiac structural and functional changes as a secondary enpoint. Patients undergoing cardiac MRI will not be asked to do the DIBH technique. However, all patients will be asked to hold their breath for short periods as part of standard protocol for cardiac MRI. Therefore, participants may or may not undergo DIBH during radiation therapy depending on individual tolerance. Patients will not undergo DIBH during cardiac MRI but will be asked to hold their breath for short periods only as part of standard protocol for MRI.

Sponsors

Princess Alexandra Hospital
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients with histologically proven left sided breast cancer requiring radiation therapy to either the left breast, left chest wall and or regional nodal areas (supraclavicular fossa and or internal mammary chain and or axilla) 2. Patients who are able to comply with DIBH 3. Patients who are unable to comply with DIBH 4. No contraindications to MRI 5. No contraindication to Gadolinium contrast (normal renal function) 6. Able to provide written informed consent 7. Available for follow -up

Exclusion criteria

1. Contraindications to MRI including but not limited to: electrically, magnetically or mechanically activated implants, vascular clips, metallic plates, cardiac stents or metal fragments in your body 2. Renal function (eGFR < 60mL/min/1.73m2) 3. Ccontraindication for Gadolinium contrast including but not limited to allergy to gadolinium 2.4. Claustrophobia

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026