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

Launched by TANG XIAODONG · Oct 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique using a special dye called ICG (indocyanine green) to help doctors find and remove giant cell tumors in the bones of the limbs more effectively. These tumors can sometimes leave behind small pieces that might cause them to come back after treatment. The goal of this study is to see if using this fluorescent imaging during surgery can help identify any leftover tumor cells, potentially reducing the chance of the tumor returning in the future.

To be eligible to participate, individuals must be between 18 and 65 years old, have a confirmed diagnosis of a giant cell tumor in their limb, and have not received certain medications before surgery. They should also be healthy enough to undergo the procedure without any severe liver or kidney issues. Participants will have a surgery called intralesional curettage, where the tumor will be removed and the area will be filled with bone cement. Before agreeing to join, they will be informed about the study's risks and benefits. This trial is currently looking for participants, and everyone's involvement can help improve treatment options for future patients.

Gender

ALL

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.