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Device

Magseed Localization for Breast Cancer (MAGELLAN Trial)

N/A

Recruiting

Led By Abigail Caudle, MD, MS

Research Sponsored by Endomagnetics Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed cT0-4, N1 breast cancer

Clip placed in the sampled axillary lymph node before initiation of chemotherapy

Must not have

Prior history of breast cancer in the ipsilateral breast

Prior ipsilateral axillary surgical procedure including SLND or axillary node excision

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time of surgery

Awards & highlights

Summary

This trial is to test how well Magseed/Sentimag works in guiding surgeons to remove axillary lymph nodes in patients with breast cancer who have received neo-adjuvant chemotherapy.

Who is the study for?

This trial is for adults over 18 with a specific type of breast cancer that has spread to axillary lymph nodes, and who are planning to have chemotherapy before surgery. They must be in good enough health to undergo the procedure (ECOG 0-2) and not have distant metastases, inflammatory breast cancer, previous similar surgeries or radiation in the area, a history of lymphoma or certain cardiac devices.

What is being tested?

The study tests Magseed/Sentimag's effectiveness for marking and guiding surgical removal of affected axillary lymph nodes in patients after they've had chemotherapy. It aims to provide evidence on whether this method is successful for long-term localization during targeted dissection.

What are the potential side effects?

While the description doesn't specify side effects, typical ones from using magnetic markers like Magseed may include discomfort at the marker site, minor bleeding or bruising post-procedure. Surgical risks also apply when removing marked lymph nodes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer has spread to nearby lymph nodes but not to distant parts of the body.

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A clip was placed in my lymph node before starting chemotherapy.

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I am 18 years old or older.

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I am scheduled for chemotherapy before surgery to remove my tumor.

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My cancer has spread to the lymph nodes under my arm, confirmed by a biopsy.

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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had breast cancer in the same breast before.

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I have had surgery on the same side's armpit area before.

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I have had radiation therapy to my breast or underarm area.

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My cancer has spread to distant parts of my body.

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I have inflammatory breast cancer.

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I have a history of lymphoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 42 days post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 42 days post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 42 days post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Retrieval rate of clipped node and Magseed in the excised specimen

Secondary study objectives

Ease of surgical localization

Radiologic placement accuracy

Radiologic rated ease of Magseed placement

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Magseed markerExperimental Treatment1 Intervention

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.

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Endomagnetics IncLead Sponsor

3 Previous Clinical Trials

309 Total Patients Enrolled

2 Trials studying Breast Cancer

189 Patients Enrolled for Breast Cancer

M.D. Anderson Cancer CenterOTHER

3,039 Previous Clinical Trials

1,799,636 Total Patients Enrolled

147 Trials studying Breast Cancer

63,212 Patients Enrolled for Breast Cancer

Abigail Caudle, MD, MSPrincipal InvestigatorMD Anderson Cancer Center, Houston, TX

Media Library

Magseed Marker (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03796559 — N/A

Breast Cancer Research Study Groups: Magseed marker

Breast Cancer Clinical Trial 2023: Magseed Marker Highlights & Side Effects. Trial Name: NCT03796559 — N/A

Magseed Marker (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03796559 — N/A

~13 spots leftby Feb 2026

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