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Recruiting 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

Phase I / Phase II Interventional Giant Cell Tumor of Bone

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICG (Indocyanine Green).
Who it may be relevant to
Registry conditions: Giant Cell Tumor of Bone. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • local recurrence rate of tumor [Time frame: From surgery to 2 years after surgery]
Secondary outcome measures (2)
  • Accuracy of ICG prediction tumor residuals [Time frame: From surgery to 2 weeks after surgery]
  • Correlation between fluorescence intensity and pathology findings of tumor residuals [Time frame: From surgery to 2 weeks after surgery]

Eligibility criteria

Inclusion criteria

  • . 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.

Exclusion criteria

  • . 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University People's Hospital — Beijing

Identifiers

NCT: NCT06647901 · PKUPH-ICGGCT-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗