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NCT Number: NCT06979115

Investigation Into the Safety and Efficacy of ICG-Labeled Fluorescence Imaging Technology in Guiding the Resection of Bone and Soft Tissue Tumors

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed diagnosis of bone and soft tissue tumors (according to the WHO Classification of Tumours of Soft Tissue and Bone, 4th Edition).
  • Medically fit to undergo surgical treatment based on preoperative evaluation.
  • Absence of cardiovascular, anesthesia-related, or other surgical contraindications.

Exclusion criteria

  • Presence of severe or chronic kidney, liver, or pulmonary diseases.
  • Autonomous thyroid nodules or allergy to iodine/shellfish.
  • Deemed unable to tolerate surgery based on preoperative evaluation.

Treatment and study plan

Indocyanine Green (ICG)

Drug

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.

Primary outcomes

  1. Positive Surgical Margin Rate

    Time frame: Within 4 days post-surgery (upon receipt of final pathology report)

    The proportion of cases with tumor cells detected at the surgical margin during postoperative pathological examination, used to assess the completeness of tumor resection.

  2. Positive Residual Lesion Detection Rate

    Time frame: Within 4 days post-surgery (upon receipt of final pathology report)

    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.

  3. Tumor Fluorescence Staining Rate

    Time frame: During surgery

    The success rate of intraoperative tumor visualization using fluorescence imaging after indocyanine green (ICG) injection, evaluating the effectiveness of fluorescence-guided technology.

Secondary outcomes

  1. Local Progression-Free Survival

    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

    The time from surgery to local tumor recurrence or progression, primarily assessing the efficacy of surgery in delaying recurrence.

  2. 2-Year Disease-Free Survival (DFS) Rate

    Time frame: Form surgery to 2 years after surgery

    The proportion of patients without tumor recurrence or death within 2 years post-surgery, reflecting intermediate-term treatment efficacy and overall prognosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Yan Yuan, Ph.D.

CONTACT

[email protected]

8613178504143

Zhang Yu, Ph.D.

CONTACT

[email protected]

8613602744495

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Acronym: ICG-BST

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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