Magseed Marker for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast Cancer+1 MoreMagseed Marker - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Breast Cancer
  • Axillary Lymph Nodes

Treatment Effectiveness

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Between completion of NAC time of surgery

After completion of NAC
Radiologic seed position
Between completion of NAC time of surgery
Radiologic placement accuracy
Time of Magseed marker placement
Radiologic rated ease of Magseed placement
Time of surgery
Ease of surgical localization
Retrieval rate of clipped node and Magseed in the excised specimen
Surgical nodes localized
Day 42
Rates of device and serious device-related events

Trial Safety

Trial Design

1 Treatment Group

Magseed marker
1 of 1

Experimental Treatment

65 Total Participants · 1 Treatment Group

Primary Treatment: Magseed Marker · No Placebo Group · N/A

Magseed marker
Device
Experimental Group · 1 Intervention: Magseed Marker · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: between completion of nac time of surgery

Who is running the clinical trial?

M.D. Anderson Cancer CenterOTHER
2,805 Previous Clinical Trials
1,790,314 Total Patients Enrolled
141 Trials studying Breast Cancer
31,135 Patients Enrolled for Breast Cancer
Endomagnetics IncLead Sponsor
3 Previous Clinical Trials
309 Total Patients Enrolled
2 Trials studying Breast Cancer
189 Patients Enrolled for Breast Cancer
Abigail Caudle, MD, MSPrincipal InvestigatorMD Anderson Cancer Center, Houston, TX

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histologically confirmed cT0-4, N1 breast cancer.
You have axillary lymph node metastasis with pathologic confirmation by needle biopsy.
The patient has a positive axillary lymph node.
You are planned for neo-adjuvant chemotherapy prior to surgical resection.