RecruitingPhase 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

China45 participantsStarted 2024-08-23

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. . 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 criteria

✕. . 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.

What they're measuring

local recurrence rate of tumor

Timeframe: From surgery to 2 years after surgery

Trial details

NCT IDNCT06647901

SponsorTang Xiaodong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

Contact for this trial

Han Wang, MD

+86 13520170664 wh23333@126.com

View on ClinicalTrials.gov More Giant Cell Tumor of Bone trials