Accuracy of Indocyanine Green (ICG) Fluorescence Imaging in Giant Cell Tumor of Bone Surgery

NCT07315828 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Phase

Phase 4

Started

2026-01-02

Last updated

2026-01-05

Condition(s) studied

Giant Cell Tumor of Bone

Investigational drug(s) / intervention(s)

Indocyanine Green

Indocyanine Green: Participants receive an intravenous injection of Indocyanine Green (ICG) at a dose of 0.25-0.5 mg/kg, 1-6 hours prior to surgery. Intraoperatively, a near-infrared fluorescence imaging system is used to guide the exploration of the bone cavity. The intervention involves a "verify first, treat later" protocol: it includes diagnostic verification sampling of fluorescence-positive areas and, crucially, therapeutic supplementary curettage of residual fluorescent lesions that were missed during standard white-light surgery.

Study summary

This study evaluates the diagnostic accuracy of Indocyanine Green (ICG) fluorescence imaging in visualizing residual lesions of Giant Cell Tumor of Bone (GCTB) in the tumor cavity during surgery. Patients diagnosed with GCTB will receive an intravenous injection of ICG prior to the operation to label tumor tissues. During the procedure, surgeons will use a near-infrared fluorescence imaging system to visualize the tumor cavity and identify potential residual lesions after standard curettage. The study aims to determine the sensitivity, specificity, positive predictive value, and negative predictive value of ICG fluorescence imaging by comparing the intraoperative fluorescence findings with the final pathological results of the validation samples.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Diagnosed with Giant Cell Tumor of Bone(GCTB), via preoperative biopsy or typical imaging (MRI), and scheduled for surgical resection. * Capable of understanding the study and voluntarily signing the written informed consent form. Exclusion Criteria: * Known severe history of allergy to Indocyanine Green (ICG) or iodine. * Severe liver dysfunction. * Women who are pregnant or lactating.

Primary outcome measure(s)

Diagnostic Accuracy of ICG Fluorescence Imaging (Sensitivity, Specificity, PPV, NPV) — From the time of surgery until the final pathology report is available, assessed up to 1 week post-operatively.
The diagnostic performance of ICG fluorescence imaging in detecting GCTB lesions will be evaluated by comparing the intraoperative fluorescence status (Positive/Negative) with the final histopathological diagnosis (Tumor/Non-tumor) of the resected specimens. The unit of analysis is the individual specimen. The following metrics will be calculated: Sensitivity, Specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV).

Trial sites (1)

Facility	City	Region	Status
Shanghai Sixth People's Hospital	Shanghai	China	Recruiting

More Shanghai Jiao Tong University Affiliated Sixth People's Hospital trials in China

High-resolution Magnetic Resonance Vessel Wall Imaging of Plaques Starting soon

Research on a Machine Learning-Based Predictive Model for Difficult Intubation Using Specific Vocal Characteristics Recruiting

Multimodal Imaging Evaluation of Vulnerability of Atherosclerotic Plaques: A Comparison of HR-VWI, OCT, and RWS Starting soon

Imaging of Intracranial and Extracranial Arterial Atherosclerotic Plaques Using Different Field Strength MRIs Recruiting

Effect of Liposomal Bupivacaine on Rebound Pain After Peripheral Nerve Block in Orthopedic Surgery. Starting soon

Other trials for the same condition

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 Recruiting

Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone Active, not recruiting

Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage Recruiting

A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07315828 on ClinicalTrials.gov ↗ ← All trials in China