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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- local recurrence rate of tumor
研究概览
简要总结
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.
详细描述
Recurrence is a problem in the treatment of giant cell tumor of bone(GCTB). With the application of high-speed burr and other adjuvant therapy (phenol, liquid nitrogen freezing, cauterization, etc.), the recurrence rate is greatly reduced, but it is still as high as 20%. The main cause of local recurrence is the difficulty in distinguishing small residual tumor lesions by the naked eye. The application of frozen section is limited due to the long-term decalcification of bone specimens.
Intraoperative near-infrared (NIR) imaging is a promising technology expected to solve the above problems. It allows for real-time scanning of a wide area with tumor showing fluorescence. Such intraoperative fluorescent signals provide objective evidence for the surgeon and are more reliable than subjective visual and tactile information.
This study aims to explore whether ICG-based NIR imaging guided curettage could find small residual tumors and reduce the recurrence rate of GCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •. 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.
研究组 & 干预措施
ICG group
干预措施: ICG (Indocyanine Green) (Drug)
结局指标
主要结局
local recurrence rate of tumor
时间窗: From surgery to 2 years after surgery
To explore whether based on ICG-based-NIR fluorescence imaging assisted intralesional curettage can reduce the local recurrence rate of giant cell tumor of bone in limbs.
次要结局
- Accuracy of ICG prediction tumor residuals(From surgery to 2 weeks after surgery)
- Correlation between fluorescence intensity and pathology findings of tumor residuals(From surgery to 2 weeks after surgery)
研究者
Tang Xiaodong
Dr.
Peking University People's Hospital