Image-guided Breast Surgery in the Advanced Multimodality Image Guided Operating Suite (AMIGO)
Condition: Stage I Breast Carcinoma; Stage II Breast Carcinoma
MeSH terms: Carcinoma; Breast Neoplasms
Study type: Interventional

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.
    

Intervention name(s): intra-operative MRI
Intervention type(s): Device
Intervention description(s): Patients will undergo an MRI during surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: I-II Breast Cancer