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SCOUT Reflector for Tagging Lymph Nodes for Targeted Removal in Patients With Breast Cancer

Stage IIIC Breast Cancer AJCC v7 Clinical Trial

Official title:
Using Radar Technology to Tag Abnormal Lymph Nodes for Removal During Surgery Following Neoadjuvant Chemotherapy

Clinical Trial 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 surgery. The SCOUT localization system with the SAVI reflector is non-radioactive and completely internal so can be placed into an abnormal lymph node prior to chemotherapy treatment, which theoretically will allow easier identification and therefore more reliable targeting of the abnormal lymph node for surgical removal.

Clinical Trial 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, confirmed by presence of clip, biopsy changes or treatment-related changes on pathology. SECONDARY OBJECTIVES: I. Total number of lymph nodes removed. II. Percentage of patients in which clipped node was a sentinel node. III. Percentage of patients with nodal pathologic complete response (PCR). IV. Residual cancer burden (RCB) score for patients with residual nodal disease. V. Percentage of patients requiring axillary dissection. VI. Days prior to surgery of reflector insertion. OUTLINE: Patients undergo image-guided placement of the SCOUT reflector prior to course 2 of standard of care neoadjuvant chemotherapy. Patients undergo standard of care surgery approximately 4-8 weeks after chemotherapy completion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03411070
Study type Interventional
Source Jonsson Comprehensive Cancer Center
Contact
Status Completed
Phase Early Phase 1
Start date April 7, 2019
Completion date December 6, 2021
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