NCT02057432

Image-guided Breast Surgery in the Advanced Multimodality Image Guided Operating Suite (AMIGO)

A Pilot Study to Evaluate Image-guided Breast Conserving Surgery in the Advanced Multimodality Image Guided Operating Suite (AMIGO)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This research study is a pilot study designed to evaluate magnetic resonance imaging-guided therapy (MRT) as a possible treatment for breast cancer. In this pilot study, the investigators are studying if it is possible to use intra-operative MRI to guide surgery. The therapy takes place in the Advanced Multimodality Image Guided Operating (AMIGO) suite at Brigham and Women's Hospital. The purpose of this study is to investigate if it is possible to perform the breast conserving surgery with the help of intra-operative magnetic resonance imaging in the advanced multimodality image guided operating suite. It is hoped that intra operative MRI may improve the surgeon's ability to know the exact margins of tumor. Currently, approximately 40% of women need to come back to the operating room and have the margins of the cancer re-excised.

Detailed description

The treatment being studied consists of standard lumpectomy and sentinel node biopsy if indicated, or standard axillary dissection if clinically indicated. The study includes the additional use of MRI to guide the removal of the cancer. The MRI uses powerful magnets linked to a computer to create detailed pictures of the breast. The purpose of the current study is to find out whether performing the intra-operative MRI is possible, safe and practical. As part of the study the participant will need to have tests to show that they are eligible to participate in the research study.If the participant does not meet the eligibility criteria, they will not be able to participate in this research study. Surgery Day * Wire localization with ultrasound, Mammogram or MRI in the non-palpable tumor is placed in the participant's breast. The presence of the wire in the tumor will then help guide the surgeon to the location of the tumor. * The sentinel node biopsy or axillary dissection will be performed if indicated. * Then the lumpectomy will be performed. * The participant will undergo an intra-operative MRI scan in the AMIGO. ---If the MRI images indicate there may be tumor behind, more tissue will be removed from the respective margins. No additional MRIs will be performed. * Most of these operations are outpatient. However, the need to stay overnight may occur if the recovery from anesthesia is slow or if the participant underwent an axillary dissection. Within six weeks after patient surgery. The participant will have the following procedures: * History and physical exam * Wound check * The participant will also be informed of the final pathology, including margin status.The remainder of follow up will be as per standard of care after breast conserving surgery for breast cancer. The participant will be assessed by physical exam for possible complications and local recurrence. These visits will likely overlap with established oncology care team follow-up visits.

Conditions

• Stage I Breast Carcinoma
• Stage II Breast Carcinoma

Interventions

Type	Name	Description
DEVICE	intra-operative MRI	Patients will undergo an MRI during surgery.

Timeline

• Start date: 2012-04-01
• Primary completion: 2016-01-01
• Completion: 2016-08-01
• First posted: 2014-02-07
• Last updated: 2017-01-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study