Indocyanine green fluorescence imaging to visualize tenosynovial giant cell tumor during surgery.
A Prospective Study Evaluating the Accuracy of Indocyanine Green Fluorescence Imaging in Detecting Lesions During Tenosynovial Giant Cell Tumor Surgery
PHASE4 · Shanghai Jiao Tong University Affiliated Sixth People's Hospital · NCT07315841
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 | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Jiao Tong University Affiliated Sixth People's Hospital (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07315841 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults diagnosed with localized or diffuse tenosynovial giant cell tumor who are scheduled for surgical resection and can provide informed consent.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai
- Shanghai Sixth People's Hospital — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Qingcheng Yang, Prof.
- Email: tjyqc@163.com
- Phone: +86 21 6431 9181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tenosynovial Giant Cell Tumor, Indocyanine Green, Fluorescence Imaging, Near-Infrared Imaging