Study to Evaluate the Safety and Effectiveness of Localizing Biopsy-Proven Metastatic Axillary Lymph Nodes in Women with Breast Cancer Using Magseed Markers as an Alternative to the Current Practice of Placing Radioactive Seed Markers
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-004803
NCT ID: NCT03718455
Sponsor Protocol Number: 18-004803
About this study
The purpose of this study is to evaluate if Magseed is a viable alternative to radioactive seed as a localization method for biopsy proven metastatic breast carcinoma following neoadjuvant chemotherapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Women 18 years or older
- Neoadjuvant chemotherapy planned prior to surgical excision
- Scheduled for target axillary lymph node dissection including the localized lymph node and sentinel lymph node
Exclusion Criteria:
- Pregnant or nursing women
- Allergy to lidocaine or gadolinium
- Contraindication to MRI (i.e. pacemaker)
- Axillary Infection
- Prior axillary radiation
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Genevieve Woodard, M.D., Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available