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

Stage IIIA Breast Cancer AJCC v7 Clinical Trial

Official title:

A Prospective, Open Label Study of the Use of Magseed® and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-Proven Metastases in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03038152
• Other study ID #: 2016-0806
• Secondary ID: NCI-2017-0064920
• Status: Completed
• Phase: Phase 4
• Start date: April 11, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: March 2021
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVE: I. To provide evidence that the clipped lymph node and Magseed can be successfully retrieved in the excised surgical specimen when Magseed and Sentimag are used for targeted axillary dissection in breast cancer patients. OUTLINE: Patients receive the Magseed marker via ultrasound guided injection into the previously clipped lymph node or within perinodal tissue =< 3 mm from the clipped node. Patients then undergo axillary lymph node localization and targeted dissection within 30 days. After completion of study, patients are followed up within 6-22 days post-surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Carcinoma Metastatic in Lymph Node
• Breast Neoplasms
• 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

Intervention

Procedure:
• Axillary Lymph Node Dissection
Undergo targeted axillary lymph node dissection
• Localization
Undergo axillary lymph node localization

Device:
• Medical Device
Receive Magseed via ultrasound guided injection

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Radiologist rated ease of Magseed placement	Descriptive statistics will be used to summarize the radiologist rated ease of Magseed placement. Logistic regression models and/or linear regression models will be used to assess the association of variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.	Up to 15 months
Secondary	Accuracy of Magseed placement	Will be defined as accurate, marginal or inadequate. Descriptive statistics will be used to summarize accuracy of placement. Logistic regression models and/or linear regression models will be used to assess the association of variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.	Up to 15 months
Secondary	Surgeon rated ease of node localization and removal	Descriptive statistics will be used to summarize surgeon rated ease of localization. Logistic regression models and/or linear regression models will be used to assess the association of the above mentioned variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.	Up to 15 months
Secondary	Number of nodes retrieved within the surgical specimen containing the Magseed	Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed. Logistic regression models and/or linear regression models will be used to assess the association of the above mentioned variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.	Up to 15 months
Secondary	Transcutaneous detection rate	Descriptive statistics will be used to summarize transcutaneous detection rate. Logistic regression models and/or linear regression models will be used to assess the association of the above mentioned variables with patient's characteristics in multivariate setting. Other statistical methods, when appropriate, may be used for analysis.	Up to 15 months

External Links

•   University of Texas MD Anderson Cancer Center Website