A Comparison of Intra-Operative Digital Specimen Mammography to Standard Specimen Mammography
Before the research starts patients will undergo some screening procedures to determine if
patients are eligible to participate. This includes a medical history and an assessment of
the patient's breast abnormality by mammogram and/or ultrasound and/or breast MRI. Patients
will not need to undergo any extra procedures apart from those needed by the patient's
surgeon to plan the patient's breast surgery. If the screening process shows that a patient
is eligible to participate in this research study, the patient will be enrolled and the
study will proceed on the day of surgery. If a patient does not meet the eligibility
criteria the patient will not be able to participate in this research study.
Patients will be assigned to one of two arms of this study on the day of your surgery.
Because no one knows which of the breast specimen imaging options is best, patients will be
"randomized" into one of the study groups: the Standard Specimen Mammography arm or, the
Intra-operative Specimen Mammography arm. Randomization means that the patient is put into a
group by chance. It is like flipping a coin. Neither the patient nor the surgeon will choose
what group the patient will be in.
If the patient is in the Standard Specimen Mammography arm, the patient's breast specimen
(biopsy or lumpectomy) will be taken to the Breast Imaging department for a mammogram, which
is the way breast specimens are typically imaged. If the patient is in the Intra-Operative
Specimen Mammography arm, the patient's breast specimen will be imaged right in the
operating room at the time of the surgery. The patient's images will also be linked to the
Breast Imaging department, so the radiologist can confirm the surgeon's findings.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Comparison of Operative Time Savings
To compare the overall operative time savings using intra-operative digital mammography compared with standard specimen mammography. This will be reported as minutes in the operating room.
Michelle Specht, MD
Massachusetts General Hospital
United States: Institutional Review Board
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