NCT01929395

A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Supine MRI	A limitation of MRI studies of the breast is that MRI exams are performed with the patient prone and the breasts in a pendant position, which is markedly different than the position of the breast when the patient is supine on the Operating Room table. The spatial information the surgeon receives from the prone MRI about the site of the tumor in the breast is hard to mentally translate into the actual site of the tumor in the breast of a supine patient prepared for surgery.

Timeline

• Start date: 2009-09-01
• Primary completion: 2018-03-01
• Completion: 2018-07-01
• First posted: 2013-08-27
• Last updated: 2019-04-30
• Results posted: 2019-04-30

Locations

1 site across 1 country: United States