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Trial Title:
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
NCT ID:
NCT06647901
Condition:
Giant Cell Tumor of Bone
Conditions: Official terms:
Giant Cell Tumors
Bone Neoplasms
Giant Cell Tumor of Bone
Conditions: Keywords:
ICG
Giant cell tumor of bone
curettage
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ICG (Indocyanine Green)
Description:
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.
Arm group label:
ICG group
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Status:
Recruiting
Contact:
Last name:
Han Wang, MD
Phone:
+86 13520170664
Email:
wh23333@126.com
Start date:
August 23, 2024
Completion date:
August 31, 2028
Lead sponsor:
Agency:
Tang Xiaodong
Agency class:
Other
Source:
Peking University People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06647901
