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Artificial Intelligence-Assisted 4D Dynamic Long-Axial PET Imaging for the Detection of Early Pancreatic Cancer Lesions

2026年11月3日 更新者:LI BIAO、Ruijin Hospital

Pancreatic ductal adenocarcinoma (PDAC) is associated with a poor prognosis, and early detection of pancreatic lesions is of great importance for improving patient outcomes. In this study, whole-body imaging with FDG and FAPI will be used to visualize the early development of pancreatic cancer lesions from multiple perspectives, including glucose metabolism, tumor fibrotic stroma, and integrin receptor expression. Furthermore, leveraging the advantages of four-dimensional dynamic long-axial PET imaging, artificial intelligence-assisted lesion detection and analysis will be performed to characterize lesions and differentiate between benign and malignant lesions. The imaging findings will subsequently be compared with postoperative histopathological results to evaluate the diagnostic performance of the proposed imaging approaches.

研究概览

研究类型

观察性的

注册 (估计的)

50

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Shanghai、中国、200025
        • 招聘中
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with suspected pancreatic tumors treated at Ruijin Hospital

描述

Inclusion Criteria:

  • Patients with suspected pancreatic tumors larger than 1.0 cm.
  • No histopathological diagnosis available before enrollment.
  • No prior treatment for the suspected pancreatic tumor.
  • Histopathological diagnosis obtained through surgery or biopsy within 2 months after PET imaging.
  • Able and willing to provide written informed consent.
  • Willing and able to comply with the study procedures and follow-up requirements.
  • Male or female, aged 18-75 years.
  • In generally good health, with an estimated life expectancy of more than 6 months and able to tolerate the imaging procedures.

Exclusion Criteria:

  • Severe concomitant diseases that, in the investigator's judgment, make participation in the study inappropriate, including severe cardiopulmonary dysfunction or severe hepatic or renal impairment.
  • Pregnancy, suspected pregnancy, or breastfeeding.
  • Poor compliance with the study procedures.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:OTHER
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Patients with Suspected Pancreatic Lesions

Participants with suspected pancreatic lesions undergoing PET imaging will be enrolled in this prospective observational study. Imaging approaches may include FDG and FAPI PET, with four-dimensional dynamic long-axial PET imaging and artificial intelligence-assisted lesion detection and characterization. Imaging findings will be evaluated for lesion detection and benign-malignant differentiation and compared with postoperative histopathological results when available.

Routine PET imaging performed as part of clinical care will be evaluated in this prospective observational study. Four-dimensional dynamic long-axial PET imaging and artificial intelligence-assisted image analysis will be used for pancreatic lesion detection and characterization, including differentiation between benign and malignant lesions. Imaging findings will be compared with histopathological results when available.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Diagnostic Performance of Dynamic PET Imaging for Pancreatic Lesion Characterization
大体时间:Within 2 months after PET imaging

The diagnostic performance of 4D dynamic long-axial PET imaging combined with artificial intelligence-assisted lesion detection and analysis will be evaluated for the detection and differentiation of benign and malignant pancreatic lesions. Imaging findings will be compared with postoperative histopathological results as the reference standard

Within 2 months after PET imaging

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年11月15日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2029年7月31日

研究注册日期

首次提交

2026年11月3日

首先提交符合 QC 标准的

2026年11月3日

首次发布 (实际的)

2026年11月9日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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