RecruitingPhase 1Phase 2NCT06647901

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

Sponsor

Tang Xiaodong

Enrollment

45 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

Giant Cell Tumor of Bone

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

. Aged 18-65.
Biopsy confirmed giant cell tumor of bone.
The lesions located in the limbs.
This operation is the initial treatment.
Denosumab and diphosphonates are not used before surgery.
Planned operation is intralesional curettage and filling bone defects with bone cement.
Preoperative bone scan and thin layer (layer thickness ≤3.5mm) chest CT plain scan confirmed that the lesion is a single occurrence without metastasis.
Subjects fully understand the benefits and risks of this experiment and are still willing to participate and sign the informed consent.

Exclusion Criteria4

. Known allergy to iodine contrast, indocyanine green or bone cement.
. Severe hepatic and renal insufficiency.
. During pregnancy or lactation.
. Have other malignant tumors and are receiving related medical treatment.

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Interventions

DRUGICG (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.