NCT03411070

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

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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, 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.

Conditions

• Positive Axillary Lymph Node
• Stage 0 Breast Cancer AJCC v6 and v7
• Stage I Breast Cancer AJCC v7
• Stage IA Breast Cancer AJCC v7
• Stage IB Breast Cancer AJCC v7
• Stage II Breast Cancer AJCC v6 and v7
• Stage IIA Breast Cancer AJCC v6 and v7
• Stage IIB Breast Cancer AJCC v6 and v7
• Stage III Breast Cancer AJCC v7
• Stage IIIA Breast Cancer AJCC v7
• Stage IIIB Breast Cancer AJCC v7
• Stage IIIC Breast Cancer AJCC v7

Interventions

Type	Name	Description
DEVICE	Implanted Medical Device	Undergo SCOUT reflector placement
PROCEDURE	Therapeutic Conventional Surgery	Undergo surgery

Timeline

• Start date: 2019-04-07
• Primary completion: 2021-12-06
• Completion: 2021-12-06
• First posted: 2018-01-25
• Last updated: 2023-01-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study