Clinical trial · Interventional
SCOUT Reflector for Tagging Lymph Nodes for Targeted Removal in Patients With Breast Cancer
Using Radar Technology to Tag Abnormal Lymph Nodes for Removal During Surgery Following Neoadjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Positive Axillary Lymph Node | — | UNRESOLVED | — |
| Stage 0 Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IA Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIB Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage II Breast Cancer AJCC v6 and v7 | — | UNRESOLVED | — |
| Stage IIIA Breast Cancer AJCC v7 | Malignant Breast Neoplasm | CURATED_BROADER |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Implanted Medical Device | Device | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (SCOUT reflector surgery)
- description
- 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.
- interventionNames
- Device: Implanted Medical Device
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (2)
- 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 (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBaker 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 34652548