Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03796559

Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Breast Cancer Axillary Lymph Nodes Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Medicine, Houston, Texas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magseed Marker

Device

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

Primary outcomes

  1. Retrieval rate of clipped node and Magseed in the excised specimen

    Time frame: Time of surgery

    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.

Secondary outcomes

  1. Rates of device and serious device-related events

    Time frame: Up to 42 days post-surgery

    Rates of device-related adverse events and serious device-related adverse events

  2. Radiologic rated ease of Magseed placement

    Time frame: Time of Magseed marker placement

    5 point Likert scale, very easy = 5, very difficult = 1

  3. Radiologic placement accuracy

    Time frame: Between completion of NAC time of surgery

    Success rate of seed placement (placement accuracy)

  4. Radiologic seed position

    Time frame: After completion of NAC

    Success rate of maintained seed position at the completion of NAC

  5. Surgical nodes localized

    Time frame: Time of surgery

    Number of nodes retrieved within the surgical specimen containing the Magseed

  6. Ease of surgical localization

    Time frame: Time of surgery

    5 point Likert scalevery easy = 5, very difficult = 1

Study contacts

Contact information is provided by the study sponsor or research team.

Matt Womack, PhD

CONTACT

[email protected]

+447851247439

Sponsors and collaborators

Lead sponsor

Endomagnetics Ltd.

Industry

Registry information

Official study 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

Acronym: MAGELLAN

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.