NCT06970275招募中不适用
A Multicentric, Observational, Post-marketing, Registry Study to Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.
XEOS Medical7 个研究点 分布在 4 个国家目标入组 850 人开始时间: 2025年11月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 850
- 试验地点
- 7
- 主要终点
- To assess the correlation between the specimen PET-CT images and final histopathological examination of the specimen.
研究概览
简要总结
This registry study aims to evaluate the effectiveness and clinical impact of specimen PET-CT imaging by analyzing the correlation between specimen PET-CT images, intraoperative interpretations, and histopathological findings. Additionally, it assesses how these imaging insights influence clinical decision-making and long-term patient outcomes. Through this comprehensive analysis in a real-world setting, the study seeks to generate valuable insights that can enhance specimen evaluation processes and ultimately improve patient care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •All patients that were scheduled for resective surgery and for whom successful high-resolution PET-CT imaging was performed on their resected specimens using the AURA 10 PET-CT. Successful imaging means that the image contains at least a portion of the primary tumor, the radiotracer injection was correctly executed and there were no technical issues that lead to an uninterpretable PET-CT image. Or all patients that are scheduled for resective surgery and for whom high-resolution PET-CT imaging will be performed on their resected specimens using the AURA 10 PET-CT.
- •Patients willing to provide informed consent for use of their relevant medical records. For retrospectively included patients with no further Long-Term Follow-Up (LTFU) data collection, a notification will be sent.
排除标准
- •Under the age of 18 years at the time of resective surgery.
- •Women who are pregnant or breastfeeding.
结局指标
主要结局
To assess the correlation between the specimen PET-CT images and final histopathological examination of the specimen.
时间窗: Perioperative
The concordance rate between the specimen PET-CT images and final histopathological examination of the specimen.
次要结局
- To assess the correlation between the intra-operative interpretation of specimen PET-CT images and histopathological examination of the specimen and its impact on clinical decision-making.(Perioperative)
- To assess the correlation between long-term follow-up clinical outcome and specimen PET-CT imaging findings.(From surgery to 3 years long term follow-up)
- To evaluate the influence of neoadjuvant treatment (NAT) on PET radiotracer uptake in specimen PET-CT imaging.(Perioperative)
- To assess the safety profile of PET-CT imaging procedures.(From surgery to 3 years long term follow-up)
- To investigate whether preoperatively available information (such as tumor subtype, anatomical location, tumor biology, size, grade or TNM classification) as well as intra-operatively available information influence specimen PET-CT images.(Perioperative)
- To investigate the influence of different PET radiotracers, activity, physiological parameters and imaging parameters on PET-radiotracer uptake and image quality in specimen PET-CT images.(Perioperative)
研究者
研究点 (7)
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