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Breast Carcinoma Metastatic in Lymph NodePhase 4NCT03038152

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

A Phase 4 study testing Axillary Lymph Node Dissection, Localization and Medical Device in people with Breast Carcinoma Metastatic in Lymph Node and Stage II Breast Cancer AJCC v6 and v7, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Axillary Lymph Node Dissection, Localization and Medical Device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
11 Apr 2017to 1 Mar 2021
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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.

Being tested
Axillary Lymph Node Dissection, Localization, Medical Device
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Axillary Lymph Node DissectionProcedure or surgery

    Also called ALND, Axillary Dissection, Axillary Lymphadenectomy, Axillary Node Dissection

    Undergo targeted axillary lymph node dissection

  • LocalizationProcedure or surgery

    Undergo axillary lymph node localization

  • Medical DeviceDevice

    Also called Device, Medical Devices

    Receive Magseed via ultrasound guided injection

Study groups in NCT03038152
Study groupRoleWhat they receive
Diagnostic (Magseed marker)ExperimentalPatients 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.
Receives: Procedure: Axillary Lymph Node Dissection; Procedure: Localization; Device: Medical Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 15 months

  2. 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.

    Measured: Up to 6 weeks post-procedure

Secondary outcomes (5)

  1. 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.

    Measured: Up to 15 months

  2. 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.

    Measured: Up to 15 months

  3. 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.

    Measured: Up to 15 months

  4. 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.

    Measured: Up to 15 months

  5. 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.

    Measured: Up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2017 (estimated)
  2. Study start11 Apr 2017
  3. Primary completion1 Mar 2021
  4. Study completion1 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03038152
Sponsor's protocol ID
2016-0806
Other IDs
NCI-2017-00649, 2016-0806
Status last verified
Mar 2021
First submitted
25 Jan 2017
Last updated
5 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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