Clinical trial · Interventional
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
NCT06647901CI-TRIAL-00081767recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Giant Cell Tumor of Bone | Giant Cell Tumor of Bone | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG (Indocyanine Green) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICG group
- interventionNames
- Drug: ICG (Indocyanine Green)
Primary outcomes (1)
- measure
- local recurrence rate of tumor
- timeFrame
- From surgery to 2 years after surgery
- description
- 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.
Secondary outcomes (2)
- measure
- Accuracy of ICG prediction tumor residuals
- timeFrame
- From surgery to 2 weeks after surgery
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.