Mayo Designed Soft Tissue Ultrasound-Detectable Marker

Breast Neoplasm Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04674852
• Other study ID #: 20-002505
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: April 7, 2022

Study information

• Verified date: January 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 7, 2022
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Ultrasound Therapy; Complications

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound detectability	Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.	Time of placement to surgical resection.
Secondary	Conspicuity compared to conventional biopsy markers and radioactive seeds	To compare conspicuity of marker with that of conventional biopsy markers and I-125 localization seeds.	Time of placement to surgical resection.

External Links

•   Mayo Clinic Clinical Trials