Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

Breast Cancer Clinical Trial

— MAGELLAN  

Official title:

A Prospective Open Label Study of the Use of Magseed® Markers and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-proven Metastases in Breast Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03796559
• Other study ID #: US-003
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: April 2025

Study information

• Verified date: February 2023
• Source: Endomagnetics Ltd.
• Contact: Matt Womack, PhD
• Phone: +447851247439
• Email: mwomack[@]endomag.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed to mark the metastatic node and are having that clipped node selectively removed at surgery following neo-adjuvant chemotherapy (NAC). Subjects will have the Magseed placed to mark axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before initiating NAC. After completion of NAC, the Magseed will be localized using the Sentimag system during surgery and removed with the targeted lymph node.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Axillary Lymph Nodes
• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Baylor Medicine	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Endomagnetics Inc	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rates of device and serious device-related events	Rates of device-related adverse events and serious device-related adverse events	Up to 42 days post-surgery
Secondary	Radiologic rated ease of Magseed placement	5 point Likert scale, very easy = 5, very difficult = 1	Time of Magseed marker placement
Secondary	Radiologic placement accuracy	Success rate of seed placement (placement accuracy)	Between completion of NAC time of surgery
Secondary	Radiologic seed position	Success rate of maintained seed position at the completion of NAC	After completion of NAC
Secondary	Surgical nodes localized	Number of nodes retrieved within the surgical specimen containing the Magseed	Time of surgery
Secondary	Ease of surgical localization	5 point Likert scalevery easy = 5, very difficult = 1	Time of surgery