Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer
Recruiting now · Phase 2
Conditions studied: Breast Cancer, DCIS, LCIS
In brief
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.
Key facts
- Study ID
- NCT03936478
- Run by
- University of Wisconsin, Madison
- People needed
- 30
- Starts
- 2022-05-16
- Expected to finish
- 2031-01-01
- Last updated by the study team
- 2026-06-11
Who can join
Age: 40 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- For all participants
- 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.
- Participants with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior and are deemed by their physician to be at low risk for recurrence. Participants with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
- For participants with Invasive Carcinoma
- Suitable:
- Age: >=50 years
- Margins: Negative by at least 2 mm
- T Stage: Tis or T1
- Cautionary:
- Age: 40-49 years
- Margins: Negative by at least 2 mm
- T Stage: Tis or T1 OR
- Age: >=50 years IF participant has at least 1 of the pathologic factors below and does not have any "unsuitable" factors (below)
- Pathologic Factors:
- Size 2.1-3.0 cm (size of the invasive component)
- T2
- Close margins (<2 mm)
- Limited/focal Lymphovascular Space Invasion (LVSI)
- ER (-)
- Clinically unifocal with total size 2.1-3.0 cm (Microscopic multifocality allowed, provided the lesion is clinically unifocal (a single discrete lesion by physical examination and ultrasonography/mammography) and the total lesion size (including foci of multifocality and intervening normal breast parenchyma) falls between 2.1 and 3.0 cm).
- Invasive lobular histology
- Extensive Intraductal Component (EIC) <=3 cm
Where it is running
- University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
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