Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Tenosynovial Giant Cell Tumor Surgery
Recruiting now · Phase 4
Conditions studied: Tenosynovial Giant Cell Tumor
In brief
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.
Key facts
- Study ID
- NCT07315841
- Run by
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- People needed
- 40
- Starts
- 2026-01-02
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-01-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosed with Tenosynovial Giant Cell Tumor (TGCT), including both Localized-type (L-TGCT) and Diffuse-type (D-TGCT), via preoperative biopsy or typical imaging (MRI), and scheduled for surgical resection.
- Capable of understanding the study and voluntarily signing the written informed consent form.
You may not qualify if…
- Known severe history of allergy to Indocyanine Green (ICG) or iodine.
- Severe liver dysfunction.
- Women who are pregnant or lactating.
Where it is running
- Shanghai Sixth People's Hospital — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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