NCT02728076

MRI-Based Preoperative Accelerated Partial Breast Irradiation

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Phase II - Preoperative Radiation followed by Lumpectomy.	Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician.

Timeline

• Start date: 2016-07-29
• Primary completion: 2021-09-16
• Completion: 2026-07-01
• First posted: 2016-04-05
• Last updated: 2026-02-19
• Results posted: 2023-01-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study