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Spots Global Cancer Trial Database for MRI-Based Preoperative Accelerated Partial Breast Irradiation

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Trial Identification

Brief Title: MRI-Based Preoperative Accelerated Partial Breast Irradiation

Official Title: Phase II Study of MRI-Based Preoperative Accelerated Partial Breast Irradiation

Study ID: NCT02728076

Conditions

Breast Cancer

Study Description

Brief Summary: This study examines the feasibility to deliver accelerated partial breast irradiation (APBI) before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The APBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is used to plan treatment. In this study, an MRI will be used. Approximately five to eight weeks after completion of the APBI, the cancer will be surgically removed.

Detailed Description: This study will examine the feasibility, complication rates, cosmetic results and local control rate of 3D conformal radiation therapy (CRT) confined to the region of the lumpectomy cavity for patients with Stage I and IIa (less than or equal to 3 cm) carcinoma of the breast (non-lobular histology) treated with APBI using 3D-CRT before lumpectomy. This study also will test the feasibility of MRI-based treatment planning for preoperative accelerated partial breast irradiation and compare dosimetric data from treatment planning with patients treated on a previous institutional post-op APBI protocol. It will also look at overall survival rates. Correlative studies include measuring the changes in tumor gene expression and immune response to radiation therapy and correlate this with pathologic response.

Eligibility

Minimum Age: 40 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Contact Details

Name: Adam Currey, MD

Affiliation: Medical College of Wisconsin

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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