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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of surgery
Awards & highlights
MAGELLAN Trial 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.Check my eligibility
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.See study design
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.
MAGELLAN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
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.
MAGELLAN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Retrieval rate of clipped node and Magseed in the excised specimen
Secondary outcome measures
Ease of surgical localization
Radiologic placement accuracy
Radiologic rated ease of Magseed placement
+3 moreMAGELLAN 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.
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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
2,972 Previous Clinical Trials
1,787,234 Total Patients Enrolled
147 Trials studying Breast Cancer
63,221 Patients Enrolled for Breast Cancer
Abigail Caudle, MD, MSPrincipal InvestigatorMD Anderson Cancer Center, Houston, TX
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am eligible for a specific lymph node removal surgery after chemotherapy.My breast cancer has spread to nearby lymph nodes but not to distant parts of the body.I have had breast cancer in the same breast before.I have had surgery on the same side's armpit area before.I have had radiation therapy to my breast or underarm area.A clip was placed in my lymph node before starting chemotherapy.My cancer has spread to distant parts of my body.I have inflammatory breast cancer.I am 18 years old or older.I am scheduled for chemotherapy before surgery to remove my tumor.My cancer has spread to the lymph nodes under my arm, confirmed by a biopsy.I have a history of lymphoma.You have a pacemaker or other implanted heart device on the same side of your chest where the treatment will be given.I can take care of myself and perform daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Magseed marker
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has this trial opened its recruitment of participants yet?
"According to clinicaltrials.gov, the study is actively seeking out participants and was originally published on June 13th 2019 with an amendment made on 14th June 2022."
Answered by AI
To what extent is this experiment being tested on human participants?
"Affirmative, the clinical trial is currently enrolling participants. According to information on clinicaltrials.gov, it was initially posted in June 2019 and last updated this month with a goal of recruiting 65 applicants from 3 sites."
Answered by AI
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