Giant Cell Tumor of Bone
Conditions
Keywords
ICG, Giant cell tumor of bone, curettage
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.
Interventions
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.
Sponsors
Tang Xiaodong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 ≤3.5mm) 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| local recurrence rate of tumor | 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
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of ICG prediction tumor residuals | From surgery to 2 weeks after surgery | To explore the accuracy of ICG fluorescence in detection of small residual tumor lesions and calculate the sensitivity, specificity, positive predictive value, negative predictive value. |
| Correlation between fluorescence intensity and pathology findings of tumor residuals | From surgery to 2 weeks after surgery | To explore the correlation between ICG fluorescence intensity and accuracy of detection of residual tumor lesions. |
Countries
China
Contacts
Primary ContactHan Wang, MD
Backup ContactXiaodong Tang, MD
Outcome results
None listed