Indocyanine green fluorescence imaging to visualize tenosynovial giant cell tumor during surgery.
Official title: A Prospective Study Evaluating the Accuracy of Indocyanine Green Fluorescence Imaging in Detecting Lesions During Tenosynovial Giant Cell Tumor Surgery
Run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital · NCT07315841 · Data updated 2026-11-12
This will test whether injecting indocyanine green helps surgeons see tumor tissue under near-infrared imaging in people having surgery for tenosynovial giant cell tumor.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Shanghai Jiao Tong University Affiliated Sixth People's Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | January 2, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT07315841 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults diagnosed with localized or diffuse tenosynovial giant cell tumor who are scheduled for surgical resection and can provide informed consent.
✕Probably not a fit
People with a known severe allergy to indocyanine green or iodine, severe liver dysfunction, or who are pregnant or breastfeeding are not eligible and would not benefit from this procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center, single-arm study gives eligible TGCT patients an intravenous injection of indocyanine green 1–3 hours before surgery and uses a near-infrared camera to visualize fluorescent tissue during the operation. After standard resection under white light, the surgical bed will be systematically scanned and the surgeon will collect samples from fluorescence-positive areas and fluorescence-negative background tissue. All specimens will undergo blinded pathological review to determine true tumor presence. The study will report sensitivity, specificity, positive and negative predictive values and perform secondary analyses such as tumor-to-background ratios and microscopic boundary concordance.
Why it matters
Potential benefit: If successful, this method could help surgeons more completely remove TGCT tissue and reduce the risk of recurrence.
How similar studies have gone: ICG fluorescence has been useful for intraoperative imaging in several tumor types, but its specific use for TGCT is relatively novel and not yet well established.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Shanghai Sixth People's Hospital
Shanghai, China Recruiting
Study contacts
- Study coordinator: Qingcheng Yang, Prof.
- Email: tjyqc@163.com
- Phone: +86 21 6431 9181
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.