Stage I Breast Carcinoma, Stage II Breast Carcinoma
Conditions
Keywords
I-II Breast Cancer
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.
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.
Interventions
DEVICEintra-operative MRI
Patients will undergo an MRI during surgery.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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). * Participants must have measurable disease, defined as one lesion that can be accurately measured by MRI. (More than one lesion will be an
Exclusion criteria
for BCS; lesions not identified by MRI will also be an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To demonstrate feasibility of using the intra-operative MRI for breast conserving surgery | 2 Years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the Lumpectomy and Imaging | 2 Years | To measure duration of the lumpectomy portion of the procedure, the duration of the imaging portion of the procedure, and time under anesthesia. |
| Final Pathology Report and Intra-operative MRI Comparison | 2 Years | The intra-operative MRI images will be compared to final pathology report which is the gold standard. This objective is for the purpose of collecting preliminary data for planning a future study which will be adequately powered to show the sensitivity and true positives of the intraoperative MRI. |
| Number of operations needed to obtain clear margins if clear margins were not obtained on initial operation. | 2 Years | Number of operations needed to obtain clear margins if clear margins were not obtained on initial operation. |
| Volume of tissue removed on initial operation and on secondary operations if these were necessary. | 2 Years | Volume of tissue removed on initial operation and on secondary operations if these were necessary. |
Countries
United States
Outcome results
None listed