Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

NCT03796559 | Recruiting FDA Device

• 1 other identifier: US-003
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following neo-adjuvant chemotherapy (NAC) is effective.

Conditions

Breast Cancer; Axillary Lymph Nodes

Keywords

Neo-adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Retrieval rate of clipped node and Magseed in the excised specimen

  The retrieval rate of the clipped node and Magseed in the excised specimen. This is defined as the number of subjects in whom the clipped node and Magseed are retrieved in a single excised specimen divided by the total number of subjects.

  Time of surgery

Secondary Outcomes (6)

• Rates of device and serious device-related events

  Up to 42 days post-surgery

• Radiologic rated ease of Magseed placement

  Time of Magseed marker placement

• Radiologic placement accuracy

  Between completion of NAC time of surgery

• Radiologic seed position

  After completion of NAC

• Surgical nodes localized

  Time of surgery

Study Arms (1)

Magseed marker

EXPERIMENTAL

Magseed marker deployed percutaneously, prior to patient undergoing neo-adjuvant chemotherapy (NAC), under ultrasound guidance to mark a lymph node intended for selective surgical removal post NAC.

Device: Magseed Marker

Interventions

Magseed Marker DEVICE

Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.

Magseed marker

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older at time of consent
• Histologically confirmed cT0-4, N1 breast cancer
• Axillary lymph node metastasis with pathologic confirmation by needle biopsy
• Clip placed in the sampled axillary lymph node before initiation of chemotherapy
• Planned for neo-adjuvant chemotherapy prior to surgical resection
• Eligible for targeted axillary dissection (defined as selective localization and removal of the clipped node and SLND) at the completion of neo-adjuvant chemotherapy
• ECOG performance status 0-2

You may not qualify if:

• Distant metastases
• Inflammatory breast cancer
• Prior ipsilateral axillary surgical procedure including SLND or axillary node excision
• Prior history of breast cancer in the ipsilateral breast
• History of lymphoma
• Subject is pregnant
• Previous radiation to the breast or axilla
• Pacemaker or other implantable cardiac device in the ipsilateral chest wall

Sponsors & Collaborators

• Endomagnetics Ltd.: lead

Study Sites (2)

Baylor Medicine

Houston, Texas, 77030, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Abigail Caudle, MD, MS

  MD Anderson Cancer Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matt Womack, PhD

CONTACT

+447851247439; mwomack@endomag.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: January 8, 2019
• Study Start: June 13, 2019
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)