Clinical trial · Observational
Investigation Into the Safety and Efficacy of ICG-Labeled Fluorescence Imaging Technology in Guiding the Resection of Bone and Soft Tissue Tumors
NCT06979115CI-TRIAL-00089895ICG-BSTnot yet recruitingClinicalTrials.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)
Investigate the application protocol, feasibility, and efficacy of indocyanine green (ICG)-assisted near-infrared (NIR) fluorescence-guided resection in bone and soft tissue tumors. Assess the incidence of adverse events and evaluate the safety of the protocol.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Neoplasms | Bone Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Soft Tissue Neoplasms | Soft Tissue Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green (ICG) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ICG Fluorescence Group
- description
- For patients with bone and soft tissue tumors, indocyanine green (ICG) is administered intravenously preoperatively. A tailored surgical plan is developed based on tumor location, anatomical complexity, histological subtype, and tumor stage. During surgery, a near-infrared (NIR) fluorescence imaging system is utilized for real-time intraoperative imaging and fluorescence-guided verification of tumor margins. Postoperatively, pathological examination of resected specimens is performed, and the positive margin rate is calculated based on histopathological findings.
- interventionNames
- Drug: Indocyanine green (ICG)
Primary outcomes (3)
- measure
- Positive Surgical Margin Rate
- timeFrame
- Within 4 days post-surgery (upon receipt of final pathology report)
- description
- The proportion of cases with tumor cells detected at the surgical margin during postoperative pathological examination, used to assess the completeness of tumor resection.
- measure
- Positive Residual Lesion Detection Rate
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed diagnosis of bone and soft tissue tumors (according to the WHO Classification of Tumours of Soft Tissue and Bone, 4th Edition). 2. Medically fit to undergo surgical treatment based on preoperative evaluation. 3. Absence of cardiovascular, anesthesia-related, or other surgical contraindications. Exclusion Criteria: 1. Presence of severe or chronic kidney, liver, or pulmonary diseases. 2. Autonomous thyroid nodules or allergy to iodine/shellfish. 3. Deemed unable to tolerate surgery based on preoperative evaluation.
References
Publications (0)
Data not yet available
No reference posted for this study.