Researchers are trying to determine if the Mayo marker is easily seen with ultrasound making it easier, faster, and more accurate for preoperative localization of the biopsied positive lymph node.
Nonrandomized clinical trial to evaluate the Mayo-designed marker for ultrasound conspicuity at the time of preoperative ultrasound-guided localization. Study participants are breast cancer patients with pathology-proven metastatic axillary lymph nodes. Per standard of care, a biopsy marker will have already been associated with the positive lymph node. 10 such patients scheduled for surgery at Mayo Clinic Rochester, MN with Dr. James Jakub will be enrolled. Preoperative radioactive seed localization will proceed as usual, but the marker will be additionally loaded with the seed into the needle using standard protocol. Before surgery, ultrasound will be performed to evaluate the marker.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
8
The research marker is a cylindrical-shaped marker made of an FDA-approved material that can be seen by ultrasound.
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Ultrasound detectability
Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.
Time frame: Time of placement to surgical resection.
Conspicuity compared to conventional biopsy markers and radioactive seeds
To compare conspicuity of marker with that of conventional biopsy markers and I-125 localization seeds.
Time frame: Time of placement to surgical resection.
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