An observational study in Bone Neoplasms and Soft Tissue Neoplasms, sponsored by Guangdong Provincial People's Hospital. Not yet recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Guangdong Provincial People's Hospital · Observational
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.
This research focuses on improving surgical outcomes for patients with bone and soft tissue tumors, a challenging area of cancer treatment. Surgeons face a critical dilemma: removing too much tissue can permanently harm a patient's mobility or function, while removing too little risks leaving behind cancer cells, which may lead to recurrence. Current methods rely heavily on the surgeon's experience and real-time visual or tactile feedback during surgery, but these approaches can be subjective and may miss hidden tumor cells. Traditional tools like frozen tissue analysis during surgery are time-consuming, disrupt the operation, and may not provide accurate results, especially for bone tumors, which require complex processing.
To address these challenges, this study explores an innovative imaging technology called near-infrared (NIR) fluorescence guided surgery, which uses a safe, FDA-approved dye called indocyanine green (ICG). ICG is injected into the patient before surgery and glows under special infrared light, helping surgeons "see" cancer cells in real time. This technology has already proven effective in other cancers (e.g., liver, breast, and colorectal tumors) by highlighting hard-to-detect lesions, guiding lymph node removal, and ensuring complete tumor excision. However, its use in bone and soft tissue tumors-a field with unique anatomical and biological complexities-remains understudied.
Key Goals of the Study:
Tumor Visualization: Test how effectively ICG can "light up" bone and soft tissue tumors under NIR imaging, and determine the optimal timing and methods for administering the dye.
Precision Surgery: Evaluate whether NIR-guided surgery helps surgeons achieve cleaner tumor margins (i.e., removing all cancer cells while sparing healthy tissue).
Accuracy Validation: Compare the fluorescent imaging results with post-surgery pathology reports to confirm if the technology reliably predicts tumor presence.
Practical Insights: Identify factors that might affect the stability and reliability of the imaging system in real-world surgical settings.
Why This Matters:
For Patients: This technology could reduce the risk of cancer recurrence, minimize unnecessary tissue removal, and improve recovery outcomes.
For Surgeons: It offers an objective, real-time tool to enhance decision-making during complex tumor surgeries.
For Cancer Care: If successful, it could establish new standards for precision in orthopedic oncology and inspire broader applications in other understudied cancers.
Real-World Examples:
In liver cancer surgery, ICG has helped surgeons detect tiny, hidden metastases that standard imaging missed.
For lung metastases from sarcoma, ICG-guided removal of suspicious tissue led to a high rate of confirmed cancer cells in additional samples.
Safety and Accessibility:
ICG is widely used in other medical fields, with a strong safety profile approved by global regulatory agencies. The study builds on existing evidence while addressing gaps specific to bone and soft tissue tumors.
By bridging the gap between advanced imaging technology and the unique needs of orthopedic oncology, this research aims to empower surgeons with better tools and give patients a stronger chance at lasting recovery
258 studies on the registry are indexed under Bone Neoplasms; 68 are open to participants now.
This study's planned enrollment of 40 is below the median of 101 across 82 observational studies indexed under Bone Neoplasms.
Browse Bone Neoplasms studies →Guangdong Provincial People's Hospital is the lead sponsor of 237 studies on the registry; 102 are open to participants now.
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40
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Indocyanine green (ICG)
Indocyanine green (ICG; National Drug Approval No. H20213567, Ruida Pharmaceuticals) is administered intravenously 24 hours preoperatively at a dose of 2 mg/kg. The drug is dissolved in 250 mL of normal saline using a light-protected infusion set and infused at a constant rate over 60 minutes. Alternatively, a 0.5 mg/kg dose may be administered via IV infusion 1-3 hours before surgery.
Positive Surgical Margin Rate
The proportion of cases with tumor cells detected at the surgical margin during postoperative pathological examination, used to assess the completeness of tumor resection.
Time frame: Within 4 days post-surgery (upon receipt of final pathology report)
Positive Residual Lesion Detection Rate
The proportion of intraoperatively detected residual lesions (via fluorescence imaging) confirmed as tumor tissue by pathology, reflecting the accuracy of fluorescence imaging in identifying tumor remnants.
Time frame: Within 4 days post-surgery (upon receipt of final pathology report)
Tumor Fluorescence Staining Rate
The success rate of intraoperative tumor visualization using fluorescence imaging after indocyanine green (ICG) injection, evaluating the effectiveness of fluorescence-guided technology.
Time frame: During surgery
Local Progression-Free Survival
The time from surgery to local tumor recurrence or progression, primarily assessing the efficacy of surgery in delaying recurrence.
Time frame: From the date of surgery until the date of first documented local progression or death from any cause, whichever occurs first, assessed up to 24 months
2-Year Disease-Free Survival (DFS) Rate
The proportion of patients without tumor recurrence or death within 2 years post-surgery, reflecting intermediate-term treatment efficacy and overall prognosis.
Time frame: Form surgery to 2 years after surgery
Plan to share: No — Data might still be actively analyzed for follow-up studies, and premature sharing could compromise ongoing work or publications.
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Dec 2028, 43 months later.
Of 37 observational studies under Bone Neoplasms, half reached primary completion within 192 months of starting (the median), counting those still running; a quarter within 41. This study's planned 43 months is below that.
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Guangdong Provincial People's Hospital →