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

November 20, 2025 updated by: Chang Chen, Shanghai Pulmonary Hospital, Shanghai, China
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Nanchang
      • Jiangxi, Nanchang, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
      • Shanghai, Shanghai Municipality, China, 200433
        • Recruiting
        • Shanghai East Hospital
        • Contact:
    • Zhejiang
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo No.2 Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with non-small cell lung cancer scheduled to undergo PET-CT and pathological examinations

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2025.12.1-2026.12.1
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.
2025.12.1-2026.12.1
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.
2025.12.1-2026.12.1
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.
2025.12.1-2026.12.1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2025.12.1-2026.12.1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PETgeneration

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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