Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 75

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.

More Tenosynovial Giant Cell Tumor trials

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment40 (estimated)
SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedJanuary 2, 2026
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedJanuary 5, 2026
Trial IDNCT07315841 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

  • Shanghai Sixth People's Hospital
    Shanghai, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.