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

NCT03718455 | Terminated Results FDA Device

• 1 other identifier: 18-004803
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Evaluate if Magseed is a Viable Alternative to Radioactive Seed as a Localization Method for Biopsy Proven Metastatic Breast Carcinoma Following Neoadjuvant Chemotherapy.

  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.

  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 Outcomes (1)

• 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.

  2-22 weeks after placement of the Magseed

Study Arms (1)

Axillary Magseed

EXPERIMENTAL

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

Interventions

Axillary Magseed DEVICE

The Magseed will replace the investigators' current clinical practice of using radioactive seeds in women receiving neoadjuvant chemotherapy.

Axillary Magseed

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Terminated study due to Limited operating room availability. Data was not analyzed

Results Point of Contact

• Title: Genevieve A. Woodard, M.D., Ph.D.
• Organization: Mayo Clinic

Woodard.Genevieve@mayo.edu

507-538-3945

Study Officials

• Genevieve A Woodard

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Consultant

Model Details: 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. The Magseed is a FDA approved device for pre-surgical localization and has been recently approved for use in the axilla and for placement longer than 30 days.

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 24, 2018
• Study Start: October 30, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 5, 2020
• Results First Posted: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)