Stage I Breast Carcinoma Clinical Trial
Official title:
A Pilot Study to Evaluate Image-guided Breast Conserving Surgery in the Advanced Multimodality Image Guided Operating Suite (AMIGO)
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02278965 -
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|
Phase 1 | |
| Completed |
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|
N/A |