Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Houston

Baylor Medicine, Houston, Texas, United States, 77030

Houston

MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Endomagnetics Ltd.,

Abigail Caudle, MD, MS, PRINCIPAL_INVESTIGATOR, MD Anderson Cancer Center, Houston, TX

Study Record Dates

2026-05