Mayo Designed Soft Tissue Ultrasound-Detectable Marker

January 19, 2023 updated by: Christine U. Lee, Mayo Clinic

A Mayo-Designed Nonmetallic, Ultrasound-Detectable Marker for Metastatic Axillary Lymph Nodes in Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Device: Research Marker
The research marker is a cylindrical-shaped marker made of an FDA-approved material that can be seen by ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound detectability
Time Frame: Time of placement to surgical resection.
Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.
Time of placement to surgical resection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conspicuity compared to conventional biopsy markers and radioactive seeds
Time Frame: Time of placement to surgical resection.
To compare conspicuity of marker with that of conventional biopsy markers and I-125 localization seeds.
Time of placement to surgical resection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Christine Lee, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2020

Primary Completion (Actual)

July 26, 2021

Study Completion (Actual)

April 7, 2022

Study Registration Dates

First Submitted

December 14, 2020

First Submitted That Met QC Criteria

December 14, 2020

First Posted (Actual)

December 19, 2020

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-002505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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