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NCT03411070 Clinical Trial

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 Details — Status: Completed

Administrative data
NCT number NCT03411070
Other study ID # 17-001864
Secondary ID NCI-2017-02394
Status Completed
Phase Early Phase 1
First received
Last updated
Start date April 7, 2019
Est. completion date December 6, 2021

Study information
Verified date January 2022
Source Jonsson Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date December 6, 2021
Est. primary completion date December 6, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Implanted Medical Device
Undergo SCOUT reflector placement
Procedure:
• Therapeutic Conventional Surgery
Undergo surgery

Locations
Country Name City State
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
Jonsson Comprehensive Cancer Center Faxitron bioptics, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with successful retrieval of reflector confirmed by specimen radiography Up to 2 years
Primary 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
Secondary Total number of lymph nodes removed Up to 2 years
Secondary Percentage of patients in which clipped node was a sentinel node Up to 2 years
Secondary Percentage of patients with nodal pathologic complete response (PCR) Up to 2 years
Secondary Residual cancer burden (RCB) score for patients with residual nodal disease Up to 2 years
Secondary Percentage of patients requiring axillary dissection Up to 2 years
Secondary Days prior to surgery of tag insertion Up to 2 years
Secondary Incidence of adverse events All adverse events due to these procedures will be recorded and reported to the institutional review board (IRB). Up to 2 years
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