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临床试验/NCT06979115
NCT06979115尚未招募不适用

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

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月25日最近更新:
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Positive Surgical Margin Rate

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

ICG Fluorescence Group

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.

干预措施: Indocyanine green (ICG) (Drug)

结局指标

主要结局

Positive Surgical Margin Rate

时间窗: 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.

Positive Residual Lesion Detection Rate

时间窗: 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.

Tumor Fluorescence Staining Rate

时间窗: During surgery

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

次要结局

  • Local Progression-Free Survival(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(Form surgery to 2 years after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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