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OpenTrials
Completed

NCT Number: NCT04674852

Mayo Designed Soft Tissue Ultrasound-Detectable Marker

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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Key information

Conditions

Breast Neoplasm Female Ultrasound Therapy; Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Research Marker

Device

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

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 19, 2020
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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