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NCT Number: NCT07243873

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

PET-CT

Diagnostic Test

A PET-CT scan is performed prior to initiating systemic treatment for the tumour.

Primary outcomes

  1. Structural similarity

    Time frame: 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.

  2. Peak Signal-to-Noise Ratio (PSNR)

    Time frame: 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.

  3. Structural Similarity Index (SSIM)

    Time frame: 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.

  4. Metabolic Parameter Consistency

    Time frame: 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.

Secondary outcomes

  1. predictive performance

    Time frame: 2025.12.1-2026.12.1

    Validation study of indicators demonstrating the added value of synthetic PET in lung cancer diagnosis: Accuracy in distinguishing benign from malignant lesions, Accuracy in diagnosing lymph node metastasis, Accuracy in diagnosing distant metastasis, Including corresponding diagnostic sensitivity, specificity, positive predictive value, negative predictive value, area under the curve (AUC), etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Xinchen Shen

CONTACT

[email protected]

17366690957

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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