RECRUITING

Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2019-06-13
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03796559

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older at time of consent
  2. * Histologically confirmed cT0-4, N1 breast cancer
  3. * Axillary lymph node metastasis with pathologic confirmation by needle biopsy
  4. * Clip placed in the sampled axillary lymph node before initiation of chemotherapy
  5. * Planned for neo-adjuvant chemotherapy prior to surgical resection
  6. * Eligible for targeted axillary dissection (defined as selective localization and removal of the clipped node and SLND) at the completion of neo-adjuvant chemotherapy
  7. * ECOG performance status 0-2
  1. * Distant metastases
  2. * Inflammatory breast cancer
  3. * Prior ipsilateral axillary surgical procedure including SLND or axillary node excision
  4. * Prior history of breast cancer in the ipsilateral breast
  5. * History of lymphoma
  6. * Subject is pregnant
  7. * Previous radiation to the breast or axilla
  8. * Pacemaker or other implantable cardiac device in the ipsilateral chest wall

Contacts and Locations

Study Contact

Matt Womack, PhD
CONTACT
+447851247439
mwomack@endomag.com

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Endomagnetics Ltd.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-13
Study Completion Date2026-05

Study Record Updates

Study Start Date2019-06-13
Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

  • Neo-adjuvant chemotherapy

Additional Relevant MeSH Terms

  • Breast Cancer
  • Axillary Lymph Nodes