NCT07315841 Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Tenosynovial Giant Cell Tumor Surgery
| NCT ID | NCT07315841 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Shanghai Jiao Tong University Affiliated Sixth People's Hospital |
| Condition | Tenosynovial Giant Cell Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-01-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2026-01-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Known severe history of allergy to Indocyanine Green (ICG) or iodine. * Severe liver dysfunction. * Women who are pregnant or lactating.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07315841 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Tenosynovial Giant Cell Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07315841 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07315841 currently recruiting?
Yes, NCT07315841 is actively recruiting participants. Contact the research team at tjyqc@163.com for enrollment information.
Where is the NCT07315841 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07315841 clinical trial?
NCT07315841 is sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital. The trial plans to enroll 40 participants.