A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Enrollment
- 159
- Locations
- 1
- Primary Endpoint
- The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a 2 Phase study. In the first phase of the study, patients with palpable invasive breast cancer underwent pre-operative supine MRI and optical scanning in the surgical position. In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.
Detailed Description
We propose to use a novel technique (optical scanning) to correlate the supine MRI image to the surgical position in the OR and then to confirm and extend the Japanese study described above. In the first phase of the study, 5-25 patients with palpable invasive breast cancer will undergo pre-operative supine MRI and optical scanning in the surgical position. The purpose of this phase will be ensure that the images created from the optical scanner-adjusted supine MRI images closely correspond to the location of the palpable tumors in these breasts. All patients will then have their tumor resected using the standard method of either palpation or image guided wire localization. The first phase has been completed. In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique. Our secondary objectives will be to determine: 1. whether there are differences between the two groups in the volume of breast tissue removed. 2. whether diagnostic information obtained from a supine MRI is equivalent to that obtained from the prone MRI.
Investigators
Richard J. Barth,Jr.
Section Chief, General Surgery
Dartmouth-Hitchcock Medical Center
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor.
Time Frame: From baseline MRI to intraoperative measurements: 30 days
Mean calculated from differences in precise distances from the nipple to the superior, inferior, medial and lateral edges of the tumor as determined from the adjusted MRI images and conventional MRI.
To Determine Whether the Addition of Supine MRI to Conventional Imaging With Mammography and Prone MRI Results in a Lower Positive Margin Rate in Patients Undergoing Breast-conserving Surgery.
Time Frame: 30 days from surgery
The primary analysis consists of computing the positive margin rate observed in the two groups and comparing them with a chi-squared test and finally comparing the proportion of patients with positive margins in the two groups based on study criteria.
Secondary Outcomes
- Differences Between the Two Groups in the Volume of Breast Tissue Removed(30 days from surgery)