NCT05693363招募中不适用
Perioperative Specimen Imaging Using High-resolution 18F-FDG-PET-CT During Thoracic Surgery: a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager
研究概览
简要总结
In this pilot study the investigators propose the intraoperative use of a high-resolution PET-CT imaging system which can assess resection margins and lymph node status in the operating room. This will allow for a faster and stepwise assessment (estimated to be under 10 minutes per specimen), enabling the surgeon to decide on subsequent surgical steps after each previous assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 years of age or older.
- •Patient with suspected or confirmed lung malignancies
- •Patient is indicated to undergo thoracic surgery.
- •Patient is estimated to be compliant for study participation by the investigator.
- •Patient has freely given his/her informed consent to participate in this study.
排除标准
- •Patient has general or local contra-indications for thoracic surgery.
- •Patient has active infection.
- •Blood glucose level over 200 mg/dL on the day of surgery.
- •Pregnancy or lactation.
- •Patient participated in other clinical studies with radiation exposure of more than 1 mSv in the past year
结局指标
主要结局
Perioperative success in imaging utilizing AURA10 PET-CT Specimen Imager
时间窗: Perioperative
A measure of perioperative success in imaging 18F-FDG- uptake in resected specimens obtained during thoracic surgery utilizing a high-resolution PET-CT-scanner.
次要结局
- Measure signal-to-noise ratio on post-processed PET-CT specimen images.(Perioperative)
- Correlation of high-resolution 18F-FDG-PET-CT images of lamellas of the resected specimen with histopathological whole-slide images.(Perioperative)
- Comparison of lesion dimensions (e.g. delineation based on percentage of SUVmax, tumor-to-background ratios based on SUVpeak).(Perioperative)
- Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected mediastinal or thoracic lymph nodes in terms of nodal staging.(Perioperative)
- Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of lung parenchyma margin assessment(Perioperative)
- Correlation between 18F-FDG uptake in the resected specimens and histopathological characteristics of the tumor, such as the type, grade, or stage of the tumor.(Perioperative)
- Occupational radiation exposure (µSv) to the staff in the operating room related to this study.(Perioperative)
- Sensitivity and specificity of high-resolution 18F-FDG-PET-CT of resected lung tumors in terms of bronchial margin assessment.(Perioperative)
研究者
研究点 (2)
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