Indocyanine green fluorescence to find leftover giant cell tumor tissue during surgery
A Prospective Study on the Accuracy of Indocyanine Green Fluorescence Imaging for the Visualization of Residual Lesions in the Tumor Cavity During Surgery for Giant Cell Tumor of Bone
PHASE4 · Shanghai Jiao Tong University Affiliated Sixth People's Hospital · NCT07315828
We will try a dye called indocyanine green with near-infrared imaging during surgery to help surgeons spot any remaining giant cell tumor tissue in people having surgery for GCTB.
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 | NCT07315828 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, single-arm study that gives patients an intravenous dose of indocyanine green (0.25–0.5 mg/kg) 1–6 hours before their planned tumor curettage. After the standard curettage under white light, surgeons will use a near-infrared fluorescence imaging system to scan the bone cavity and identify fluorescence-positive areas. Biopsy samples will be taken from fluorescence-positive sites, fluorescence-negative background, and post-treatment beds and sent for blinded pathological review. The study will compare intraoperative fluorescence findings with pathology to calculate sensitivity, specificity, positive predictive value, negative predictive value, and will also analyze tumor-to-background ratios and microscopic tumor boundary concordance.
Who should consider this trial
Good fit: People diagnosed with giant cell tumor of bone who are scheduled for surgical resection/curettage and can provide informed consent, and who have no contraindications to ICG.
Not a fit: Patients with a known severe allergy to ICG or iodine, severe liver dysfunction, pregnant or lactating women, or those whose tumors do not take up ICG or are inaccessible to near-infrared imaging may not benefit.
Why it matters
Potential benefit: If successful, this technique could help surgeons detect and remove microscopic residual tumor tissue more reliably, potentially reducing local recurrence after curettage.
How similar studies have performed: Near-infrared ICG fluorescence has shown usefulness for intraoperative visualization in other tumor types, but its use specifically for detecting residual GCTB during curettage is novel and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with Giant Cell Tumor of Bone(GCTB), 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: Giant Cell Tumor of Bone, Indocyanine Green, Fluorescence Imaging, Near-Infrared Imaging