Mayo Designed Soft Tissue Ultrasound-Detectable Marker

Not Applicable

Completed

• Conditions: Ultrasound Therapy; Complications; Breast Neoplasm Female
• Interventions: Device: Research Marker

• Registration Number: NCT04674852
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study Start: 2020-11-02
• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Primary Completion: 2021-07-26
• Study Completion: 2022-04-07
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 8

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Marking cN+ nodes	Research Marker	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.

Primary Outcome Measures

Name	Time	Method
Ultrasound detectability	Time of placement to surgical resection.	Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.

Secondary Outcome Measures

Name	Time	Method
Conspicuity compared to conventional biopsy markers and radioactive seeds	Time of placement to surgical resection.	To compare conspicuity of marker with that of conventional biopsy markers and I-125 localization seeds.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States