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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- local recurrence rate of tumor
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
ICG group
Intervention: ICG (Indocyanine Green) (Drug)
Outcomes
Primary Outcomes
local recurrence rate of tumor
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Tang Xiaodong
Dr.
Peking University People's Hospital