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Clinical Trials in China / NCT06647901
Recruiting Phase 1/2

Efficacy of ICG-based NIR Imaging in Intralesional Curettage of Giant Cell Tumors of Bone in Limbs: a Prospective, Single-center, Single-arm, Open Study

NCT06647901 · tracked via the Priya Life Science China tracker
Sponsor
Tang Xiaodong
Phase
Phase 1/2
Started
2024-08-23
Last updated
2024-10-18

Condition(s) studied

Giant Cell Tumor of Bone

Investigational drug(s) / intervention(s)

ICG (Indocyanine Green)

ICG (Indocyanine Green): Patients will be receive intravenously administrated at a dose of 2 mg/kg on the day before surgery. The drug was dissolved into 250 mL of normal saline and administered using a light-proof infusion apparatus. The time course of administration was 60 min. NIR imaging will be performed during surgery to help identify small tumor residuals.

Study summary

ICG fluorescence imaging will be applied during the intralesional curettage of giant cell tumor of bone in the limbs. This study aims to preliminarily explore whether ICG fluorescent-guided curettage could find small residual tumors and reduce the recurrence rate of tumor.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. . Aged 18-65. 2. Biopsy confirmed giant cell tumor of bone. 3. The lesions located in the limbs. 4. This operation is the initial treatment. 5. Denosumab and diphosphonates are not used before surgery. 6. Planned operation is intralesional curettage and filling bone defects with bone cement. 7. Preoperative bone scan and thin layer (layer thickness ≤3.5mm) chest CT plain scan confirmed that the lesion is a single occurrence without metastasis. 8. Subjects fully understand the benefits and risks of this experiment and are still willing to participate and sign the informed consent. Exclusion Criteria: 1. . Known allergy to iodine contrast, indocyanine green or bone cement. 2. . Severe hepatic and renal insufficiency. 3. . During pregnancy or lactation. 4. . Have other malignant tumors and are receiving related medical treatment.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Beijing Municipality Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06647901 on ClinicalTrials.gov ↗ ← All trials in China