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

Early Phase 1

Completed

• Conditions: Stage I Breast Cancer AJCC v7; Stage II Breast Cancer AJCC v6 and v7; Stage IIA Breast Cancer AJCC v6 and v7; Stage IA Breast Cancer AJCC v7; Stage IB Breast Cancer AJCC v7; Stage III Breast Cancer AJCC v7; Positive Axillary Lymph Node; Stage IIB Breast Cancer AJCC v6 and v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7
• Interventions: Device: Implanted Medical Device; Procedure: Therapeutic Conventional Surgery

• Registration Number: NCT03411070
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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 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.

Study Timeline

• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-01-19
• Study First Posted: 2018-01-25
• Study Start: 2019-04-07
• Primary Completion: 2021-12-06
• Study Completion: 2021-12-06
• Status Verified: 2022-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (SCOUT reflector surgery)	Implanted Medical Device	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.
Treatment (SCOUT reflector surgery)	Therapeutic Conventional Surgery	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.

Primary Outcome Measures

Name	Time	Method
Percentage of patients with successful retrieval of the biopsied node, confirmed by presence of clip, biopsy changes or treatment-related changes on pathology	Up to 2 years
Percentage of patients with successful retrieval of reflector confirmed by specimen radiography	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Total number of lymph nodes removed	Up to 2 years
Percentage of patients with nodal pathologic complete response (PCR)	Up to 2 years
Percentage of patients requiring axillary dissection	Up to 2 years
Days prior to surgery of tag insertion	Up to 2 years
Percentage of patients in which clipped node was a sentinel node	Up to 2 years
Residual cancer burden (RCB) score for patients with residual nodal disease	Up to 2 years
Incidence of adverse events	Up to 2 years	All adverse events due to these procedures will be recorded and reported to the institutional review board (IRB).

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States