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临床试验/NCT07243873
NCT07243873招募中不适用

Synthetic PET From CT Improves Precision Diagnosis and Treatment of Lung Cancer: a Prospective, Observational, Multicenter Study

Shanghai Pulmonary Hospital, Shanghai, China5 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2025年12月1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
10,000
试验地点
5
主要终点
Structural similarity

研究概览

简要总结

This study aims to synthesise PET data that preserves biological relevance and adds clinical value to the diagnosis and prognosis of lung cancer by establishing anatomical-to-metabolic mapping based on paired diagnostic CT and FDG-PET scans, thereby prospectively validating the clinical utility of the model.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with non-small cell lung cancer scheduled to undergo PET-CT and pathological examinations;
  • •Voluntarily participate and sign an informed consent form;

排除标准

  • •History of other malignant tumours;
  • •Image artefacts;
  • •Without pathological diagnostic information;
  • •Without paired CT and FDG-PET scan images.

结局指标

主要结局

Structural similarity

时间窗: 2025.12.1-2026.12.1

This is a core outcome measure evaluating the degree of resemblance between the structural characteristics of synthetic PET images and reference PET images. It reflects whether the synthetic PET retains the key structural information of the original image, which is a fundamental indicator for confirming the structural relevance of synthetic PET.

Peak Signal-to-Noise Ratio (PSNR)

时间窗: 2025.12.1-2026.12.1

A commonly used objective evaluation index in image quality assessment, calculated based on the mean square error between the synthetic PET image and the reference image. It quantifies the ratio of the maximum possible signal value in the image to the noise power that affects image quality. Higher PSNR values indicate that the synthetic PET image has less noise interference and better consistency with the reference image in terms of signal characteristics, thereby reflecting better retention of structural information.

Structural Similarity Index (SSIM)

时间窗: 2025.12.1-2026.12.1

An index designed to simulate human visual perception to evaluate image structural similarity, which comprehensively considers three aspects: brightness, contrast, and structural consistency between the synthetic PET image and the reference image. The value range is between 0 and 1; a value closer to 1 means that the synthetic PET image has a higher degree of structural consistency with the reference image, indicating that the structural relevance is well retained.

Metabolic Parameter Consistency

时间窗: 2025.12.1-2026.12.1

A key outcome measure for verifying the biological relevance of synthetic PET, which evaluates whether the metabolic characteristic parameters derived from synthetic PET are consistent with those from reference PET. Metabolic parameters are directly related to the biological functions of tissues/organs, so their consistency is crucial to ensuring that synthetic PET can be used for accurate biological activity assessment.

次要结局

  • predictive performance(2025.12.1-2026.12.1)

研究者

发起方
Shanghai Pulmonary Hospital, Shanghai, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang Chen

Chief Physician

Shanghai Pulmonary Hospital, Shanghai, China

研究点 (5)

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