A Mayo-Designed Nonmetallic, Ultrasound-Detectable Marker for Metastatic Axillary Lymph Nodes in Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Ultrasound detectability
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node
- •Surgical management involves preoperative radioactive seed localization of a previously identified positive axillary lymph node
- •Surgery will be performed by Dr. James Jakub at Mayo Clinic Rochester, MN
- •Radioactive seed localization of an axillary lymph node.
- •No contraception is necessary or required.
- •English speaking
Exclusion Criteria
- •Scheduled for only radioactive seed localizations in the breast (as opposed to axilla)
- •Are pregnant; although the twinkling marker is made of material widely used in orthopedic procedures, and hence, has an excellent safety profile, the investigators want to exclude the population of pregnant patients in this phase 0 clinical trial.
Arms & Interventions
Marking cN+ nodes
These patients have already undergone neoadjuvant chemotherapy for locally advanced breast cancer with metastasis to the axillary lymph nodes. During standard of care needle-directed I-125 seed localization, the research marker will also be deployed through the same needle. Ultrasound detection of the marker will be compared to conventional biopsy markers and the I-25 seed.
Intervention: Research Marker (Device)
Outcomes
Primary Outcomes
Ultrasound detectability
Time Frame: Time of placement to surgical resection.
Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.
Secondary Outcomes
- Conspicuity compared to conventional biopsy markers and radioactive seeds(Time of placement to surgical resection.)
Investigators
Christine U. Lee
Principal Investigator
Mayo Clinic