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NCT06085274: SHINE

Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)

Recruiting now NA Last updated 19 December 2025
What this trial tests

NA trial testing ICG guided sentinel lymph node biopsy in Breast Cancer in 100 participants. Currently enrolling.

Timeline
3 September 2025
Primary endpoint
30 April 2026
30 April 2026

Quick facts

Lead sponsorUniversity Health Network, Toronto
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment100
Start date3 September 2025
Primary completion30 April 2026
Estimated completion30 April 2026
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

University Health Network, Toronto

Who can join

Adults 18 to 80, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, open-label, within-patient clinical trial to determine the accuracy of Indocyanine green (ICG) guided sentinel lymph node biopsy (SLNB) compared to the standard dual-tracer SLNB in breast cancer patients who have had chemotherapy as a first treatment using a non-inferiority design. Patients with operable breast cancer treated with chemotherapy and eligible for SLNB will be included in the study. During surgery, ICG will be injected and used to identify fluorescent sentinel nodes using a hand-held imaging camera; radiotracer and blue dye will also be used as per standard protocols. Intraoperative and clinicopathologic outcomes such as complications, characteristics of nodes, false negative rates and feasibility will be assessed. Patients will be asked to complete standardized patient reported outcome questionnaires (Breast-Q, FACT-B+4, VAS) to define the patient experience with this novel technique.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Axillary lymph node dissection in triple-negative or HER2-positive breast cancer patients with clinical N2 achieving pathological complete response after neoadjuvant therapy: Is it necessary?
    Guo X, Zhang J, Gong X, Wang J, et al · · 2024 · cited 5× · PMID 38277714 · DOI 10.1016/j.breast.2024.103671

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other University Health Network, Toronto trials

Trials by the same sponsor.

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Data sources for this page

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