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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG (Indocyanine Green) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| local recurrence rate of tumor | 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. | From surgery to 2 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of ICG prediction tumor residuals | 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. | From surgery to 2 weeks after surgery |
| Correlation between fluorescence intensity and pathology findings of tumor residuals |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Han Wang, MD | Contact | +86 13520170664 | wh23333@126.com | |
| Xiaodong Tang, MD | Contact | +86 8832 6150 | tang15877@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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To explore the correlation between ICG fluorescence intensity and accuracy of detection of residual tumor lesions. |
| From surgery to 2 weeks after surgery |
| ID | Term |
|---|---|
| D018212 | Giant Cell Tumor of Bone |
| ID | Term |
|---|---|
| D005870 | Giant Cell Tumors |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018213 | Neoplasms, Bone Tissue |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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