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Real-Time MRI-Guided Radiation for Early Breast Cancer

This study is testing a new way to give radiation therapy for early breast cancer, including DCIS (ductal carcinoma in situ) and LCIS (lobular carcinoma in situ). It uses an MRIdian Radiation Treatment Unit to deliver partial breast irradiation in just three treatments over one week. The goal is to reduce the amount of healthy tissue exposed to radiation, which could mean fewer side effects. Researchers want to see if this shorter, more targeted treatment is safe and effective. You may be able to join if you are a woman aged 40 or older, have early breast cancer, and can have an MRI. The study is looking for 30 participants, but its current recruitment status is unclear. Success will be measured by how good the treated breast looks one year after treatment, as reported by your doctor.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
Participants will receive three radiation treatments over one week. You can expect to be followed by the study team for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03936478

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

Recruiting
PHASE2Ages 40+InterventionalTreatment
University of Wisconsin, Madison
~30 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:MRIdian Radiation Treatment Unit

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Physician Reported Cosmesis: 1-year
Measured over up to 1-year

Conditions

Breast Cancer
DCIS
LCIS

Explore related trials

Breast CarcinomaBreast Ductal Carcinoma In SituLobular carcinoma in situ

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Bethany Anderson, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Cancer Connect
[email protected]
800-622-8922
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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.
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
Suitable Criteria, DCIS allowed if all of the following are met:
Screen-detected
Low to intermediate nuclear grade
Size \<=2.5 cm
Resected with margins negative at \>=3mm OR
Cautionary Criteria:
Pure DCIS \<=3 cm if "suitable" criteria not fully met

Exclusion

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).
Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
Suspicious micro calcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
Non-epithelial breast malignancies such as sarcoma or lymphoma.
Proven multicentric carcinoma (invasive cancer or DCIS) (ASTRO Unsuitable Criteria).
Pure DCIS \>3 cm in size (ASTRO Unsuitable Criteria).
Presence of extensive intraductal component \>30mm (ASTRO Unsuitable Criteria).
Paget's disease of the nipple.
History of previous invasive breast cancer, DCIS, synchronous bilateral invasive or non-invasive breast cancer. (Participants with a history of LCIS treated by surgery alone are eligible.)
Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
Concurrent therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, Aromatase Inhibitors or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention or neoadjuvant therapy.
Breast implants.
Prior breast or thoracic radiotherapy for any condition or treatment plan that includes regional nodal irradiation.
Collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.
Pregnancy or lactation at the time of treatment. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the participant from meeting the study requirements.

What this trial measures

  • Physician Reported Cosmesis: 1-yearup to 1-year

    The Harvard Cosmesis Scale will be used to report cosmesis at 1 year post treatment. The physician will report how the breast looks relative to original appearance or untreated breast (excellent, good, fair, poor). The physician answers 9 questions on a scale of 0-2 where 0 is none, 1 is present but does not affect cosmesis, 2 is present and affects cosmesis. Scoring is objective with lower scores indicating improved conditions.