Status:
COMPLETED
SCOUT Reflector for Tagging Lymph Nodes for Targeted Removal in Patients With Breast Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Faxitron bioptics, LLC
Conditions:
Positive Axillary Lymph Node
Stage 0 Breast Cancer AJCC v6 and v7
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This pilot clinical trial will evaluate whether the SCOUT reflector can be used to tag abnormal lymph nodes in patients with breast cancer prior to chemotherapy for targeted removal at the time of sur...
Detailed Description
PRIMARY OBJECTIVES: I. Percentage of patients with successful retrieval of the reflector confirmed by specimen radiography. II. Percentage of patients with successful retrieval of the biopsied node,...
Eligibility Criteria
Inclusion
- Able to give written informed consent to participate in the study
- Patients with a breast cancer diagnosis of any subtype and a biopsy-proven positive axillary lymph node who will be treated first with chemotherapy
- Enlarged lymph node and/or clip targetable with image guidance
- Patients who are eligible for surgical resection of the primary breast cancer and targeted dissection of the axilla
Exclusion
- More than 3 positive axillary nodes on imaging or matted nodes on clinical exam
- Stage IV breast cancer
- Pregnant or lactating females
- Patients with inflammatory breast cancer
- Patients with allergies to isosulfan blue or technetium, which would preclude sentinel node mapping
- Patients who have had previous axillary surgery, including sentinel lymph node biopsy
Key Trial Info
Start Date :
April 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03411070
Start Date
April 7 2019
End Date
December 6 2021
Last Update
January 17 2023
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095