Magseed Magnetic Marker in Locating Axillary Lymph Nodes in Patients With Breast Cancer Undergoing Surgery

NCT03038152 | Completed Phase 4

• 2 other identifiers: 2016-0806NCI-2017-00649
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This phase IV trial studies the side effects of the Magseed magnetic marker and how well it works in locating lymph nodes in the underarm area in patients with breast cancer undergoing surgery. Injecting a small metallic marker in or near the lymph node prior to surgery may help the surgeon locate the lymph nodes during surgery without using radiation.

Conditions

Breast Carcinoma Metastatic in Lymph Node; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7

Outcome Measures

Primary Outcomes (2)

• Retrieval rate

  Will be 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. For the analysis of retrieval rate, if the trial is not stopped early and all 50 patients are accrued, then point estimate along with 95% credible interval will be provided. Logistic regression model will be utilized to assess the association of patient demographic and clinical factors with the retrieval.

  Up to 15 months

• Incidence of adverse events

  Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicity data will be summarized by frequency tables. For the toxicity endpoint, per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.

  Up to 6 weeks post-procedure

Secondary Outcomes (5)

• Radiologist rated ease of Magseed placement

  Up to 15 months

• Accuracy of Magseed placement

  Up to 15 months

• Surgeon rated ease of node localization and removal

  Up to 15 months

• Number of nodes retrieved within the surgical specimen containing the Magseed

  Up to 15 months

• Transcutaneous detection rate

  Up to 15 months

Study Arms (1)

Diagnostic (Magseed marker)

EXPERIMENTAL

Patients receive the Magseed marker via ultrasound guided injection into the previously clipped lymph node or within perinodal tissue =\< 3mm from the clipped node. Patients then undergo axillary lymph node localization and targeted dissection within 30 days.

Procedure: Axillary Lymph Node Dissection; Procedure: Localization; Device: Medical Device

Interventions

Axillary Lymph Node Dissection PROCEDURE

Undergo targeted axillary lymph node dissection

Also known as: ALND, Axillary Dissection, Axillary Lymphadenectomy, Axillary Node Dissection, Excision Axillary Lymph Nodes

Diagnostic (Magseed marker)

Localization PROCEDURE

Undergo axillary lymph node localization

Diagnostic (Magseed marker)

Medical Device DEVICE

Receive Magseed via ultrasound guided injection

Also known as: Device, Medical Devices

Diagnostic (Magseed marker)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 completing chemotherapy
• Received neoadjuvant chemotherapy prior to surgical resection
• Scheduled for targeted axillary dissection (defined as selective localization and removal of the clipped node and sentinel lymph node dissection \[SLND\])
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

You may not qualify if:

• Distant metastases
• Inflammatory breast cancer
• Prior surgical axillary procedure including SLND or axillary node excision
• Prior history of breast cancer in the ipsilateral breast
• History of lymphoma
• The subject is known to be pregnant. Premenopausal patients under the age of 50 must have a pregnancy test performed as standard of care before the MagSeed is placed
• Previous radiation to the breast or axilla
• Pacemaker of other implantable device in the chest wall

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Abigail S Caudle

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 31, 2017
• Study Start: April 11, 2017
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

US (1)