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

NCT03411070 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-01-17

No results posted yet for this study

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.

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

DEVICE

Implanted Medical Device

Undergo SCOUT reflector placement

PROCEDURE

Therapeutic Conventional Surgery

Undergo surgery

Sponsors & Collaborators

  • Faxitron bioptics, LLC

    collaborator UNKNOWN

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Jennifer Baker, MD · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-07
Primary Completion
2021-12-06
Completion
2021-12-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03411070 on ClinicalTrials.gov