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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

RecruitingPhase 1, Phase 2Ages 18 Years - 65 YearsAllTang Xiaodong
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค3.5mm) 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.
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What it tests

  • ICG (Indocyanine Green)
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Where

1 site
Peking University People's Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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