NCT03411070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Apr 2019

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 7, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2021

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2022

Enrollment Period

2.7 years

First QC Date

January 19, 2018

Last Update Submit

January 12, 2023

Conditions

Positive Axillary Lymph NodeStage 0 Breast Cancer AJCC v6 and v7Stage I Breast Cancer AJCC v7Stage IA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7Stage II Breast Cancer AJCC v6 and v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7Stage III Breast Cancer AJCC v7Stage IIIA Breast Cancer AJCC v7Stage IIIB Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7

Outcome Measures

Primary Outcomes (2)

  • Percentage of patients with successful retrieval of reflector confirmed by specimen radiography

    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

    Up to 2 years

Secondary Outcomes (7)

  • Total number of lymph nodes removed

    Up to 2 years

  • Percentage of patients in which clipped node was a sentinel node

    Up to 2 years

  • Percentage of patients with nodal pathologic complete response (PCR)

    Up to 2 years

  • Residual cancer burden (RCB) score for patients with residual nodal disease

    Up to 2 years

  • Percentage of patients requiring axillary dissection

    Up to 2 years

  • +2 more secondary outcomes

Study Arms (1)

Treatment (SCOUT reflector surgery)

EXPERIMENTAL

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.

Device: Implanted Medical DeviceProcedure: Therapeutic Conventional Surgery

Interventions

Implanted Medical DeviceDEVICE

Undergo SCOUT reflector placement

Also known as: IMPLANTED
Treatment (SCOUT reflector surgery)
Therapeutic Conventional SurgeryPROCEDURE

Undergo surgery

Treatment (SCOUT reflector surgery)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Baker JL, Haji F, Kusske AM, Fischer CP, Hoyt AC, Thompson CK, Lee MK, Attai D, DiNome ML. SAVI SCOUT(R) localization of metastatic axillary lymph node prior to neoadjuvant chemotherapy for targeted axillary dissection: a pilot study. Breast Cancer Res Treat. 2022 Jan;191(1):107-114. doi: 10.1007/s10549-021-06416-z. Epub 2021 Oct 15.

    PMID: 34652548DERIVED

MeSH Terms

Conditions

Breast Carcinoma In SituBreast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jennifer Baker, MD

    UCLA / Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 25, 2018

Study Start

April 7, 2019

Primary Completion

December 6, 2021

Study Completion

December 6, 2021

Last Updated

January 17, 2023

Record last verified: 2022-01

Locations

US(1)