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

NCT02057432 | Completed DMC FDA Device

• 1 other identifier: 11-454
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Stage I Breast Carcinoma; Stage II Breast Carcinoma

Keywords

I-II Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To demonstrate feasibility of using the intra-operative MRI for breast conserving surgery

  For the purpose of this pilot study, feasibility is defined as the ability to successfully complete the breast conserving operation in the AMIGO suite. Feasibility must entail the following: All necessary instruments for this operation are MRI compatible or are able to be used safely and then stored outside of the magnetic field when the intra-operative MRI is performed. The intra-operative MRI is performed without compromising the sterile operative field.

  2 Years

Secondary Outcomes (4)

• Duration of the Lumpectomy and Imaging

  2 Years

• Final Pathology Report and Intra-operative MRI Comparison

  2 Years

• Number of operations needed to obtain clear margins if clear margins were not obtained on initial operation.

  2 Years

• Volume of tissue removed on initial operation and on secondary operations if these were necessary.

  2 Years

Study Arms (1)

Intra-operative MRI

EXPERIMENTAL

Images will be obtained both before and after intravenous bolus injection with subsequent dynamic imaging. Dynamic contrast enhancement maps will be created for evaluation of residual tumor. Images will be reformatted into three orthogonal planes as well as into a 3D model for surgical orientation. All imaging protocols using contrast, contrast enhancement maps and reformatting, as described above, which will be applied to the intra-operative MRI performed in the AMIGO suite are consistent with the standard MRI breast imaging at Brigham and Women's Hospital.

Device: intra-operative MRI

Interventions

intra-operative MRI DEVICE

Patients will undergo an MRI during surgery.

Intra-operative MRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have a pre-operative standard mammogram with or without ultrasound. These may be performed at outside institutions.
• Participants must have biopsy confirmed invasive breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at BWH/DFCI.
• Stage: Clinical Staging must be Stage I or II as outlined by the AJCC 7th edition. Pre-operative diagnosis of positive axillary nodes necessitating axillary dissection at the time of lumpectomy does not disqualify a patient.
• Pre-operative sentinel node biopsy also does not disqualify the patient.
• Participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for BCS, and the ability to undergo standard radiation therapy post-operatively).

You may not qualify if:

• Age ≥ 18 years and \< 75.
• Completion of the magnetic resonance (MR) procedure screening form and clearance by the MR technologist that the patient does not have a pacemaker, brain aneurysm clip, inner ear implant, neurostimulator or metal fragments in the eye.
• Ability to understand and the willingness to sign a written informed consent document.
• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• Participants with a known BRCA 1 or 2 mutation.
• Participants with known Li-Fraumeni or Cowden's Disease.
• Participants with prior mantle radiation.
• Participants with locally advanced breast cancer such as inflammatory breast cancer or cancer grossly involving skin.
• Participants who are pregnant.
• Participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy. The neoadjuvant chemotherapy can result in complete pathologic response, resulting in no signal on MRI.
• Participants with known, active collagen vascular disease.
• Participants who undergo breast surgery at an outside institution.
• Participants with prior history of breast carcinoma.
• Patients who have implants or any type of breast reconstruction.
• Patients who have biopsy confirmed multi-centric disease.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mehra Golshan, MD

  Dana Farber Cance Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2014
• First Posted: February 7, 2014
• Study Start: April 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)