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

January 12, 2023 updated by: Jonsson Comprehensive Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (SCOUT reflector 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.
Procedure: Therapeutic Conventional Surgery
Undergo surgery
Device: Implanted Medical Device
Undergo SCOUT reflector placement
Other Names:
  • IMPLANTED

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

Faxitron bioptics, LLC

Investigators

  • Principal Investigator: Jennifer Baker, MD, UCLA / Jonsson Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2019

Primary Completion (Actual)

December 6, 2021

Study Completion (Actual)

December 6, 2021

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-001864
  • NCI-2017-02394 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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