Recruiting

Observational Study

Sponsor:

Endomagnetics Ltd.

Code:

NCT03796559

Conditions

Breast Cancer

Axillary Lymph Nodes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magseed Marker

Study Details

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

Study ID

NCT03796559

Start date

Jun 13, 2019

Status verified date

Aug, 2024

Completion date

May, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Magseed marker

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.

Interventions

Magseed Marker

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

Primary outcome measure

  • Retrieval rate of clipped node and Magseed in the excised specimen [ Time Frame: Time of surgery ]

Central Contacts and Locations

Central contacts

Matt Womack, PhD

+447851247439mwomack@endomag.com

Locations

Baylor Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Ivan Marin

ivan.marin@bcm.edu

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Veronika Noregil

VYNovegil@mdanderson.org

More Information

Sponsor

Endomagnetics Ltd.

Last update posted

Sep 19, 2024

Last verified

Aug, 2024

Keywords

  • Neo-adjuvant chemotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endomagnetics Ltd. on 2024-09-19.