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ICG Fluorescence Imaging for GCTB Surgery
NCT07315828Phase 4
Key facts
- Status
- Recruiting
- Start
- Jan 2026
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Shanghai Sixth People's Hospital
- Modality
- Small Molecules
- Drugs
- indocyanine green
- Conditions
- Giant Cell Tumor of Bone (GCTB)
01
Overview
Phase 4, open-label, single-arm trial of indocyanine green in Giant Cell Tumor of Bone (GCTB), sponsored by Shanghai Sixth People's Hospital. Primary endpoint: Diagnostic Accuracy of ICG Fluorescence Imaging (Sensitivity, Specificity, PPV, NPV) at 1 week. Started Jan 2026; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
ICG Fluorescence Imaging Group
Patients receive ICG injection followed by fluorescence-guided surgery and pathological validation.
03
Who it enrols
Patients diagnosed with Giant Cell Tumor of Bone scheduled for surgical resection, excluding those with severe liver dysfunction, pregnancy/lactation, or allergy to ICG/iodine.
04
Endpoints
Primary
Diagnostic Accuracy of ICG Fluorescence Imaging (Sensitivity, Specificity, PPV, NPV)
Secondary
Tumor-to-Background Ratio
Incidence of ICG-Related Adverse Events
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