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

NCT06647901 | Recruiting Phase 1

• 1 other identifier: PKUPH-ICGGCT-1
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Giant Cell Tumor of Bone

Keywords

ICG; Giant cell tumor of bone; curettage

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Accuracy of ICG prediction tumor residuals

  From surgery to 2 weeks after surgery

• Correlation between fluorescence intensity and pathology findings of tumor residuals

  From surgery to 2 weeks after surgery

Study Arms (1)

ICG group

EXPERIMENTAL

Drug: ICG (Indocyanine Green)

Interventions

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.

ICG group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-65.
• Biopsy confirmed giant cell tumor of bone.
• The lesions located in the limbs.
• This operation is the initial treatment.
• Denosumab and diphosphonates are not used before surgery.
• Planned operation is intralesional curettage and filling bone defects with bone cement.
• Preoperative bone scan and thin layer (layer thickness ≤3.5mm) chest CT plain scan confirmed that the lesion is a single occurrence without metastasis.
• Subjects fully understand the benefits and risks of this experiment and are still willing to participate and sign the informed consent.

You may not qualify if:

• Known allergy to iodine contrast, indocyanine green or bone cement.
• Severe hepatic and renal insufficiency.
• During pregnancy or lactation.
• Have other malignant tumors and are receiving related medical treatment.

Sponsors & Collaborators

• Tang Xiaodong: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Giant Cell Tumor of Bone

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Han Wang, MD

CONTACT

+86 13520170664; wh23333@126.com

Xiaodong Tang, MD

CONTACT

+86 8832 6150; tang15877@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 18, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 18, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)