NCT04674852

Mayo Designed Soft Tissue Ultrasound-Detectable Marker

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasm Female
• Ultrasound Therapy; Complications

Interventions

Type	Name	Description
DEVICE	Research Marker	The research marker is a cylindrical-shaped marker made of an FDA-approved material that can be seen by ultrasound.

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-07-26
• Completion: 2022-04-07
• First posted: 2020-12-19
• Last updated: 2023-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study