RecruitingPhase 2NCT03936478

Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer

A Phase II Study of Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer (MAPBI)


Sponsor

University of Wisconsin, Madison

Enrollment

30 participants

Start Date

May 16, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be completed in one-week (5 working days) and 2) MRI-guided radiotherapy (MRIdian) would limit the volume of normal tissue radiated and therefore resultant toxicity. The hypothesis is that 3-fraction radiation therapy can be delivered safely without compromising the therapeutic ratio. Participants can expect to be on study for follow up up to 5 years.


Eligibility

Sex: FEMALEMin Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a shorter, more targeted type of radiation treatment called accelerated partial breast irradiation (APBI) delivered in just 3 sessions using real-time MRI guidance. It is designed for people with early-stage breast cancer who have already had a lumpectomy (surgery to remove the tumor while keeping the breast). MRI guidance helps doctors focus radiation precisely on the area where cancer was, reducing exposure to surrounding healthy tissue. **You may be eligible if...** - You have had a lumpectomy for early-stage breast cancer - The area where the tumor was removed is clearly visible on MRI and CT scans - You have no contraindications to MRI scans - Your pregnancy test is negative (if applicable) - Your tumor meets specific size, margin, and grade criteria **You may NOT be eligible if...** - You have had prior radiation to the same breast - You have metal implants or other MRI incompatible devices - You are pregnant - Your cancer has spread to lymph nodes or beyond - Your tumor cavity is too close to the skin or chest wall Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONMRIdian Radiation Treatment Unit

partial breast irradiation using 3 x 8.2 Gy to the lumpectomy cavity with a 3mm planning tumor volume (PTV) margin


Locations(1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

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NCT03936478


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