CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 39 enrolled
Drug / intervention
Phase II - Preoperative Radiation followed by Lumpectomy.radiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02728076
NCT02728076N/AActive

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

Medical College of Wisconsin·interventional·Posted Apr 5, 2016·Updated Feb 19, 2026

In Brief

A clinical study evaluating Phase II - Preoperative Radiation followed by Lumpectomy. for Breast Cancer. Active but no longer recruiting, targeting 39 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

N/AActiveOverdue
20162017201820192020202120222023202420252026
First PostedApr 5, 2016
Enrollment StartJul 29, 2016
Primary CompletionSep 16, 2021
Study CompletionJul 1, 2026
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 10.2 years ago

Interventions

Phase II - Preoperative Radiation followed by Lumpectomy.radiation

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.