Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age40+
SponsorUniversity of Wisconsin, Madison
About this trial
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 criteria
Qualifiers
Participants should have no contraindications to undergo MRI scan as part of radiotherapy planning and treatment.
Lumpectomy cavity must be clearly visible on CT and MRI scan at radiotherapy simulation.
Pregnancy test negative in women of child bearing potential (WOCBP).
The participant must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
Disqualifiers
Men are not eligible for this study.
BRCA1/2 mutation positivity.
Age < 40 years (American Society for Radiation Oncology (ASTRO) Unsuitable Criteria).
Positive resection margins on post operative pathology(ASTRO Unsuitable Criteria).
Trial design
Treatments tested in this trial
- MRIdian Radiation Treatment Unit
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov