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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110875
Enrollment
Unknown
Registered
2025-10-22
Start date
2025-10-27
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Tumor of Bone

Interventions

Trial group:The patient received intravenous ICG before conventional curettage of giant cell tumor of bone. After routine intraoperative curettage, the procedure of fluorescence imaging of tumor cavit

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years, with closed epiphyseal plates. 2. Confirmed diagnosis of primary giant cell tumor of bone (GCTB) via preoperative biopsy. 3. Tumor suitable for extensive curettage, with Campanacci grade II or III. 4. Able to understand the study and voluntarily sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known severe allergy to ICG or iodine. 2. Severe liver dysfunction. 3. Female subjects who are pregnant, lactating, or planning to become pregnant during the study period. 4. Recurrent cases or those previously treated with Denosumab. 5. Cases with severe pathological fractures unsuitable for curettage.

Design outcomes

Primary

MeasureTime frame
The accuracy of ICG fluorescence imaging in displaying GCTB lesions, including sensitivity, specificity, positive predictive value and negative predictive value;

Secondary

MeasureTime frame
Spatial overlap of ICG fluorescence boundary and pathological boundary;Correlation between Microvessel Density (MVD) and Tumor-to-Background Ratio(TBR);Correlation between TBR and Campanacci classification;Incidence of Adverse Events;

Countries

China

Contacts

Public ContactYang Qingcheng

Shanghai Sixth People's Hospital

tjyqc@163.com+86 21 6431 9181

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026