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

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.

Study Overview

• Status: Recruiting
• Conditions: Giant Cell Tumor of Bone
• Intervention / Treatment: Drug: ICG (Indocyanine Green)

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Han Wang, MD; Phone Number: +86 13520170664; Email: wh23333@126.com
• Study Contact Backup: Name: Xiaodong Tang, MD; Phone Number: +86 8832 6150; Email: tang15877@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Han Wang, MD; Phone Number: +86 13520170664; Email: wh23333@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICG group	Drug: ICG (Indocyanine Green); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	To explore the correlation between ICG fluorescence intensity and accuracy of detection of residual tumor lesions.	From surgery to 2 weeks after surgery

Collaborators and Investigators

• Sponsor: Tang Xiaodong

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: ICG; curettage; Giant cell tumor of bone
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Bone Neoplasms; Giant Cell Tumors; Giant Cell Tumor of Bone
• Other Study ID Numbers: PKUPH-ICGGCT-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No