Mayo Designed Soft Tissue Ultrasound-Detectable Marker

NCT04674852 | Completed FDA Device

• 1 other identifier: 20-002505
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasm Female; Ultrasound Therapy; Complications

Keywords

axillary lymph node; biopsy clip; biopsy marker; ultrasound

Outcome Measures

Primary Outcomes (1)

• Ultrasound detectability

  Evaluation of ultrasound conspicuity of marker placed at time of radioactive seed localization.

  Time of placement to surgical resection.

Secondary Outcomes (1)

• Conspicuity compared to conventional biopsy markers and radioactive seeds

  Time of placement to surgical resection.

Study Arms (1)

Marking cN+ nodes

OTHER

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

Interventions

Research Marker DEVICE

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

Marking cN+ nodes

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Jakub JW, Hesley GK, Larson NB, Yaszemski MJ, Lee Miller A 2nd, Greenleaf JF, Urban MW, Lee CU. Ultrasonographic Detection and Surgical Retrieval of a Nonmetallic Twinkle Marker in Breast Cancer: Pilot Study. Radiol Imaging Cancer. 2022 Nov;4(6):e220053. doi: 10.1148/rycan.220053.

  PMID: 36367449 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Christine Lee, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: November 2, 2020
• Primary Completion: July 26, 2021
• Study Completion: April 7, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)