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Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Tenosynovial Giant Cell Tumor Surgery

Study acronym: ICG-TGCT
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2026 to Jan 2, 2026
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study evaluates the diagnostic accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing Tenosynovial Giant Cell Tumor (TGCT) lesions during surgery. Patients diagnosed with TGCT will receive an intravenous injection of ICG prior to the operation to label tumor tissues. During the procedure, surgeons will use a near-infrared fluorescence imaging system to visualize the tumor and potential residual lesions in the surgical bed. The study aims to determine the sensitivity, specificity, positive predictive value, and negative predictive value of ICG fluorescence imaging by comparing the intraoperative fluorescence findings with the final pathological results of the resected tissues.
Trial Details
NCT Number NCT07315841
Lead Sponsor Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Conditions
(from sponsor)		 Tenosynovial Giant Cell Tumor
Related terms Giant Cell Tumor of Tendon Sheath
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov