Study on Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation for Early Breast Cancer

Sponsor: University of Wisconsin, Madison

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03936478

This clinical trial is testing a new radiation treatment for early breast cancer that can be completed in just one week. The study uses MRI-guided technology to target the cancer more precisely, reducing the amount of healthy tissue affected and minimizing side effects.

Patient Parameters

Program Overview

The purpose of this study is to evaluate a new radiation treatment for early breast cancer that can be completed in three sessions over one week. This approach uses MRI-guided technology to focus the radiation more accurately, which may help protect healthy tissue and reduce side effects. The study aims to determine if this treatment is safe and effective without compromising the benefits of traditional therapy. Participants will be followed for up to five years to monitor their health and the treatment's impact.

Eligibility Criteria

Inclusion Criteria

  • Must be able to undergo an MRI scan as part of the treatment planning.
  • The area where the tumor was removed must be clearly visible on scans.
  • Women of childbearing age must have a negative pregnancy test.
  • Must agree to participate and sign a consent form.
  • Can have a history of other cancers if they have been cancer-free for 5 years or more, or if they had certain types of cancer treated within the last 5 years.

For participants with Invasive Carcinoma:

  • Suitable if:
    • Age 50 or older
    • Tumor margins are clear by at least 2 mm
    • Tumor stage Tis or T1
  • Cautionary if:
    • Age 40-49 with clear margins and tumor stage Tis or T1
    • Age 50 or older with certain factors like tumor size 2.1-3.0 cm, close margins, or specific tumor characteristics

For participants with DCIS:

  • Suitable if:
    • Detected by screening
    • Low to intermediate grade
    • Size 2.5 cm or smaller
    • Margins clear by 3 mm or more
  • Cautionary if:
    • Pure DCIS 3 cm or smaller if not fully meeting suitable criteria

Exclusion Criteria

  • Men cannot participate.
  • Positive for BRCA1/2 mutation.
  • Under 40 years old.
  • Positive tumor margins after surgery.
  • Suspicious lymph nodes unless confirmed negative for cancer.
  • Suspicious breast findings unless confirmed benign.
  • Non-epithelial breast cancers.
  • Multiple cancer sites in the breast.
  • Pure DCIS larger than 3 cm.
  • Extensive intraductal component larger than 30 mm.
  • Paget's disease of the nipple.
  • History of previous breast cancer or certain other breast conditions.
  • Cannot assess or have positive surgical margins.
  • Using certain hormonal therapies.
  • Have breast implants.
  • Previous breast or chest radiation.
  • Certain collagen vascular diseases.
  • Pregnant or breastfeeding. Women must use non-hormonal contraception.
  • Conditions that prevent meeting study requirements.

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