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

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ClinicalTrials.gov Identifier: NCT03796559
Recruitment Status : Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Endomagnetics Inc

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Axillary Lymph Nodes Device: Magseed Marker Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Magseed marker
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.
Device: Magseed Marker
Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.




Primary Outcome Measures :
  1. Retrieval rate of clipped node and Magseed in the excised specimen [ Time Frame: Time of surgery ]
    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 :
  1. Rates of device and serious device-related events [ Time Frame: Up to 42 days post-surgery ]
    Rates of device-related adverse events and serious device-related adverse events

  2. Radiologic rated ease of Magseed placement [ Time Frame: Time of Magseed marker placement ]
    5 point Likert scale

  3. Radiologic placement accuracy [ Time Frame: Between completion of NAC time of surgery ]
    Success rate of seed placement (placement accuracy)

  4. Radiologic seed position [ Time Frame: After completion of NAC ]
    Success rate of maintained seed position at the completion of NAC

  5. Surgical nodes localized [ Time Frame: Time of surgery ]
    Number of nodes retrieved within the surgical specimen containing the Magseed

  6. Ease of surgical localization [ Time Frame: Time of surgery ]
    5 point Likert scale



Information from the National Library of Medicine

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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:

  • 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

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): NCT03796559


Contacts
Contact: Quentin Harmer, PhD +447894608428 qharmer@endomag.com
Contact: Clarice L Scofield, BA 6128039461 copemc1@gmail.com

Locations
United States, New Jersey
Cooper Health, MD Anderson Cancer Center Not yet recruiting
Camden, New Jersey, United States, 08103
Contact: Andrew March, MHA, CCRC    856-735-6249    march-andrew@CooperHealth.edu   
United States, Texas
MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Kelly Rodriguez, MS    713-563-1681    KMRodriguez@mdanderson.org   
Sub-Investigator: Kelly Hunt, MD, F.A.C.S.         
Sponsors and Collaborators
Endomagnetics Inc
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Abigail Caudle, MD, MS MD Anderson Cancer Center, Houston, TX

Responsible Party: Endomagnetics Inc
ClinicalTrials.gov Identifier: NCT03796559     History of Changes
Other Study ID Numbers: US-003
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Endomagnetics Inc:
Neo-adjuvant chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases