Clinical trial NCT06647901: 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Giant Cell Tumor of Bone
Keywords: ICG
Giant cell tumor of bone
curettage
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: local recurrence rate of tumor
timeFrame: From surgery to 2 years after surgery
Secondary outcomes:
measure: Accuracy of ICG prediction tumor residuals
timeFrame: From surgery to 2 weeks after surgery
measure: Correlation between fluorescence intensity and pathology findings of tumor residuals
timeFrame: From surgery to 2 weeks after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People&amp;#39;s Hospital
state: Beijing
Study officials:
References: