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Magseed Enabled Long-Term Localization of Axillary Lymph Nodes (MAGELLAN)

Primary Purpose

Breast Cancer, Axillary Lymph Nodes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magseed Marker
Sponsored by
Endomagnetics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Neo-adjuvant chemotherapy

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years or older at time of consent
  • 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 initiation of chemotherapy
  • Planned for neo-adjuvant chemotherapy prior to surgical resection
  • Eligible for targeted axillary dissection (defined as selective localization and removal of the clipped node and SLND) at the completion of neo-adjuvant chemotherapy
  • ECOG performance status 0-2

Exclusion Criteria:

  • Distant metastases
  • Inflammatory breast cancer
  • Prior ipsilateral axillary surgical procedure including SLND or axillary node excision
  • Prior history of breast cancer in the ipsilateral breast
  • History of lymphoma
  • Subject is pregnant
  • Previous radiation to the breast or axilla
  • Pacemaker or other implantable cardiac device in the ipsilateral chest wall

Sites / Locations

  • Baylor MedicineRecruiting
  • MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magseed marker

Arm Description

Magseed marker deployed percutaneously, prior to patient undergoing neo-adjuvant chemotherapy (NAC), under ultrasound guidance to mark a lymph node intended for selective surgical removal post NAC.

Outcomes

Primary Outcome Measures

Retrieval rate of clipped node and Magseed in the excised specimen
The retrieval rate of the clipped node and Magseed in the excised specimen. This is 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.

Secondary Outcome Measures

Rates of device and serious device-related events
Rates of device-related adverse events and serious device-related adverse events
Radiologic rated ease of Magseed placement
5 point Likert scale, very easy = 5, very difficult = 1
Radiologic placement accuracy
Success rate of seed placement (placement accuracy)
Radiologic seed position
Success rate of maintained seed position at the completion of NAC
Surgical nodes localized
Number of nodes retrieved within the surgical specimen containing the Magseed
Ease of surgical localization
5 point Likert scalevery easy = 5, very difficult = 1

Full Information

First Posted
November 8, 2018
Last Updated
February 15, 2023
Sponsor
Endomagnetics Inc
Collaborators
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03796559
Brief Title
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes
Acronym
MAGELLAN
Official Title
A Prospective Open Label Study of the Use of Magseed® Markers and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-proven Metastases in Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endomagnetics Inc
Collaborators
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following neo-adjuvant chemotherapy (NAC) is effective.
Detailed Description
This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed to mark the metastatic node and are having that clipped node selectively removed at surgery following neo-adjuvant chemotherapy (NAC). Subjects will have the Magseed placed to mark axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before initiating NAC. After completion of NAC, the Magseed will be localized using the Sentimag system during surgery and removed with the targeted lymph node.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Axillary Lymph Nodes
Keywords
Neo-adjuvant chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magseed marker
Arm Type
Experimental
Arm Description
Magseed marker deployed percutaneously, prior to patient undergoing neo-adjuvant chemotherapy (NAC), under ultrasound guidance to mark a lymph node intended for selective surgical removal post NAC.
Intervention Type
Device
Intervention Name(s)
Magseed Marker
Intervention Description
Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.
Primary Outcome Measure Information:
Title
Retrieval rate of clipped node and Magseed in the excised specimen
Description
The retrieval rate of the clipped node and Magseed in the excised specimen. This is 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.
Time Frame
Time of surgery
Secondary Outcome Measure Information:
Title
Rates of device and serious device-related events
Description
Rates of device-related adverse events and serious device-related adverse events
Time Frame
Up to 42 days post-surgery
Title
Radiologic rated ease of Magseed placement
Description
5 point Likert scale, very easy = 5, very difficult = 1
Time Frame
Time of Magseed marker placement
Title
Radiologic placement accuracy
Description
Success rate of seed placement (placement accuracy)
Time Frame
Between completion of NAC time of surgery
Title
Radiologic seed position
Description
Success rate of maintained seed position at the completion of NAC
Time Frame
After completion of NAC
Title
Surgical nodes localized
Description
Number of nodes retrieved within the surgical specimen containing the Magseed
Time Frame
Time of surgery
Title
Ease of surgical localization
Description
5 point Likert scalevery easy = 5, very difficult = 1
Time Frame
Time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older at time of consent 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 initiation of chemotherapy Planned for neo-adjuvant chemotherapy prior to surgical resection Eligible for targeted axillary dissection (defined as selective localization and removal of the clipped node and SLND) at the completion of neo-adjuvant chemotherapy ECOG performance status 0-2 Exclusion Criteria: Distant metastases Inflammatory breast cancer Prior ipsilateral axillary surgical procedure including SLND or axillary node excision Prior history of breast cancer in the ipsilateral breast History of lymphoma Subject is pregnant Previous radiation to the breast or axilla Pacemaker or other implantable cardiac device in the ipsilateral chest wall
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matt Womack, PhD
Phone
+447851247439
Email
mwomack@endomag.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abigail Caudle, MD, MS
Organizational Affiliation
MD Anderson Cancer Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Marin
Email
ivan.marin@bcm.edu
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronika Noregil
Email
VYNovegil@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Kelly Hunt, MD, F.A.C.S.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

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