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

Primary Purpose

Breast Carcinoma Metastatic in Lymph Node, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Axillary Lymph Node Dissection
Localization
Medical Device
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Carcinoma Metastatic in Lymph Node

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (Magseed marker)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
January 25, 2017
Last Updated
March 3, 2021
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03038152
Brief Title
Magseed Magnetic Marker in Locating Axillary Lymph Nodes in Patients With Breast Cancer Undergoing Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (Magseed marker)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Axillary Lymph Node Dissection
Other Intervention Name(s)
ALND, Axillary Dissection, Axillary Lymphadenectomy, Axillary Node Dissection, Excision Axillary Lymph Nodes
Intervention Description
Undergo targeted axillary lymph node dissection
Intervention Type
Procedure
Intervention Name(s)
Localization
Intervention Description
Undergo axillary lymph node localization
Intervention Type
Device
Intervention Name(s)
Medical Device
Other Intervention Name(s)
Device, Medical Devices
Intervention Description
Receive Magseed via ultrasound guided injection
Primary Outcome Measure Information:
Title
Retrieval rate
Description
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.
Time Frame
Up to 15 months
Title
Incidence of adverse events
Description
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.
Time Frame
Up to 6 weeks post-procedure
Secondary Outcome Measure Information:
Title
Radiologist rated ease of Magseed placement
Description
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.
Time Frame
Up to 15 months
Title
Accuracy of Magseed placement
Description
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.
Time Frame
Up to 15 months
Title
Surgeon rated ease of node localization and removal
Description
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.
Time Frame
Up to 15 months
Title
Number of nodes retrieved within the surgical specimen containing the Magseed
Description
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.
Time Frame
Up to 15 months
Title
Transcutaneous detection rate
Description
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.
Time Frame
Up to 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abigail S Caudle
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

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

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