Clinical trial NCT03411070: SCOUT Reflector for Tagging Lymph Nodes for Targeted Removal in Patients With Breast Cancer
Official title: Using Radar Technology to Tag Abnormal Lymph Nodes for Removal During Surgery Following Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
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
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Faxitron bioptics, LLC
First posted: 2018-01-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with successful retrieval of reflector confirmed by specimen radiography
timeFrame: Up to 2 years
measure: Percentage of patients with successful retrieval of the biopsied node, confirmed by presence of clip, biopsy changes or treatment-related changes on pathology
timeFrame: Up to 2 years
Secondary outcomes:
measure: Total number of lymph nodes removed
timeFrame: Up to 2 years
measure: Percentage of patients in which clipped node was a sentinel node
timeFrame: Up to 2 years
measure: Percentage of patients with nodal pathologic complete response (PCR)
timeFrame: Up to 2 years
measure: Residual cancer burden (RCB) score for patients with residual nodal disease
timeFrame: Up to 2 years
measure: Percentage of patients requiring axillary dissection
timeFrame: Up to 2 years
measure: Days prior to surgery of tag insertion
timeFrame: Up to 2 years
measure: Incidence of adverse events
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Jennifer Baker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.