Mayo Designed Soft Tissue Ultrasound-Detectable Marker

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2022-04-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Neoplasm Female Ultrasound Therapy; Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Research Marker

Intervention Type DEVICE

The research marker is a cylindrical-shaped marker made of an FDA-approved material that can be seen by ultrasound.

Interventions

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Research Marker

The research marker is a cylindrical-shaped marker made of an FDA-approved material that can be seen by ultrasound.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No