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

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ClinicalTrials.gov Identifier: NCT03038152
Recruitment Status : Completed
First Posted : January 31, 2017
Last Update Posted : March 5, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Procedure: Axillary Lymph Node Dissection Procedure: Localization Device: Medical Device Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : April 11, 2017
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Diagnostic (Magseed marker)
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
Undergo targeted axillary lymph node dissection
Other Names:
  • ALND
  • Axillary Dissection
  • Axillary Lymphadenectomy
  • Axillary Node Dissection
  • Excision Axillary Lymph Nodes

Procedure: Localization
Undergo axillary lymph node localization

Device: Medical Device
Receive Magseed via ultrasound guided injection
Other Names:
  • Device
  • Medical Devices


Outcome Measures
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Primary Outcome Measures :
  1. Retrieval rate [ Time Frame: Up to 15 months ]
    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.

  2. Incidence of adverse events [ Time Frame: Up to 6 weeks post-procedure ]
    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 :
  1. Radiologist rated ease of Magseed placement [ Time Frame: Up to 15 months ]
    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.

  2. Accuracy of Magseed placement [ Time Frame: Up to 15 months ]
    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.

  3. Surgeon rated ease of node localization and removal [ Time Frame: Up to 15 months ]
    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.

  4. Number of nodes retrieved within the surgical specimen containing the Magseed [ Time Frame: Up to 15 months ]
    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.

  5. Transcutaneous detection rate [ Time Frame: Up to 15 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038152


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Abigail S Caudle M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03038152    
Other Study ID Numbers: 2016-0806
NCI-2017-00649 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0806 ( Other Identifier: M D Anderson Cancer Center )
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases