Mayo Designed Soft Tissue Ultrasound-Detectable Marker

Mayo Clinic

Status: Completed

Conditions: Breast Neoplasm Female; Ultrasound Therapy; Complications

Treatments: Device: Research Marker

Study type: Interventional

Funder types: Other

Identifiers

NCT04674852

20-002505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Marking cN+ nodes

Other group

Description:

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.

Treatment:

Device: Research Marker