Evaluation of Magseed as Localization Device for Biopsy Proven Metastatic Axillary Lymph Nodes

September 8, 2020 updated by: Genevieve A. Woodard, Mayo Clinic

Evaluation of Magseed as Localization Device for Biopsy Proven Metastatic Axillary Lymph Nodes in Women With Breast Cancer

Currently, breast cancer patients who are treated with neoadjuvant chemotherapy (NAC) before surgery may have a biopsy clip placed in the lymph node at the time of or shortly after percutaneous biopsy. Following 12-20+ weeks of NAC, pre-surgical localization of the sampled axillary lymph node using a radioactive seed can be done up to 5 days prior to surgery. Localization of the sampled lymph node in patients with complete imaging response to NAC can be technically challenging if the biopsy clip is not sonographically visible. This study is designed to see if it is feasible to place a Magseed, which is magnetic seed, into the abnormal node either at the time of fine needle aspiration (FNA) or after NAC, just prior to surgery, and to be able to accurately identify the abnormal node at the time of surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Part 1: Ten women with biopsy proven breast cancer and metastasis to an axillary lymph node will have a Magseed placed into the metastatic lymph node AFTER neoadjuvant chemotherapy (NAC) and just prior to surgery. These patients will have a non-contrast enhanced breast MRI development study to evaluate and identify ways to reduce the artifact in the axilla created by the Magseed. Efficacy of the localization with the Magseed will be available within a week of the placement.

Part 2: Ten additional women with biopsy proven breast cancer and metastasis to an axillary lymph node will have a Magseed placed into the metastatic lymph node BEFORE NAC. These patients will have routine contrast enhanced MRIs, mammograms, and ultrasounds before and after NAC to evaluate treatment response.

Seed placement: Once a patient has been identified eligible for the research study and has provided written informed consent the patient will have a Magseed placed into the biopsy proven lymph node. The Magseed delivery system is identical to the investigators' current practice using radioactive seeds. The seed is pre-loaded into the needle and is inserted into the lymph node following local anesthesia with 1% lidocaine. Once the seed is deployed, post procedure seed location is confirmed sonographically and mammographically with tomosynthesis.

MRI: Ten no-charge limited non-contrast breast MRIs for research development purposes are available for this study through the radiology department. Phase 1 participants will enroll in the study after their pre- and post-NAC imaging has already been performed per routine clinical practice. These participants will have a single non-contrast enhanced breast MRI using the investigators' standard non-contrast sequences (axial ideal T1 and T2-weighted, axial Short-TI Inversion Recovery (STIR), and axial 3D vibrant using a dedicated breast coil, FOV 28 cm or to fit the patient size, and an image-thickness/image-increment of 5mm/1mm). A physicist will participate in the scanning of these patients to evaluate the extent of artifact in the axilla and adjacent breast tissue and optimize scanning parameters to reduce this artifact.

Phase 2 participants will enroll in the study prior to NAC and have routine contrast enhanced breast MRIs performed before and after NAC. Clinically indicated MRI scans will be charged to the patient's insurance company as this imaging is standard clinical practice. The MRI protocol will use the investigators' standard clinical sequences (axial ideal T1 and T2-weighted, axial STIR, and axial 3D vibrant using a dedicated breast coil). Once contrast is injected (gadobutrol 10mmol/10mL) 3D vibrant sequences will be obtained four times after contrast injection (FOV 28 cm or to fit the patient size, and an image-thickness/image-increment of 5mm/1mm).

Mammogram: Patients enrolled in the research study will have standard mammographic imaging before and after NAC, which will include both the breast and axilla as per routine clinical protocol.

Ultrasound: Patients enrolled in the research study will have standard sonographic imaging before and after NAC of the breast and axilla as per routine clinical protocol. Post-NAC ultrasound of the axilla will be a supplemental assessment to breast MRI as the Magseed artifact may obscure these findings.

Seed Removal: As per the current practice, patients will have targeted axillary lymph node dissection including both the localized lymph node and sentinel lymph node. Identifying the lymph node containing the Magseed will require the Sentimag handheld probe in the operating room. This device which functions similar to the gamma probe has been approved for an equipment trial starting in August of 2018. Once the lymph node has been excised a specimen radiograph will be obtained to verify removal.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women 18 years or older
  2. Neoadjuvant chemotherapy planned prior to surgical excision
  3. Scheduled for target axillary lymph node dissection including the localized lymph node and sentinel lymph node

Exclusion Criteria:

  1. Pregnant or nursing women
  2. Allergy to lidocaine or gadolinium
  3. Contraindication to MRI (i.e. pacemaker)
  4. Axillary Infection
  5. Prior axillary radiation
  6. Known allergy to bone wax, beeswax or propolis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Axillary Magseed
Single cohort of twenty women receiving neoadjuvant chemotherapy with breast cancer will have a Magseed inserted into a biopsy proven metastatic axillary lymph node for pre-surgical localization.
Device: Axillary Magseed
The Magseed will replace the investigators' current clinical practice of using radioactive seeds in women receiving neoadjuvant chemotherapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate if Magseed is a Viable Alternative to Radioactive Seed as a Localization Method for Biopsy Proven Metastatic Breast Carcinoma Following Neoadjuvant Chemotherapy.
Time Frame: 2-22 weeks after placement of the Magseed
The rate of successful placement of the Magseed into the axilla in the radiology department will be measured. Any substantial barriers to placement compared to the investigators' current clinical practice with the radioactive seed will be subjectively gathered from the radiologist and will be reported on a case-by-case basis.
2-22 weeks after placement of the Magseed
Assess the Success of Retrieval of the Magseed and Biopsy Proven Metastatic Lymph Node in the Operating Room Compared to the Current Practice With the Radioactive Seed.
Time Frame: 2-22 weeks after placement of the Magseed
The rate of successful retrieval of the Magseed from the axilla in the operating room will be measured. Any substantial barriers to retrieval compared to the investigators' current clinical practice with the radioactive seed will be subjectively gathered from the surgeon and will be reported on a case-by-cases basis.
2-22 weeks after placement of the Magseed

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determine the Amount of Artifact Created by the Magseed in the Axilla at MRI and Identify Imaging Optimization to Minimize the Artifact Produced by the Magnetic Clip.
Time Frame: 2-22 weeks after placement of the Magseed
The maximum dimension of the susceptibility artifact will be measured in centimeters with the investigator's current clinical MRI protocols. Additional MRI sequences with susceptibility artifact suppression techniques will be conducted and the maximum dimension of the susceptibility artifact will be measured in centimeters. Differences in these measurements will be analyzed.
2-22 weeks after placement of the Magseed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Genevieve A Woodard, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-004803

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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