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OpenTrials
Completed

NCT Number: NCT05430841

Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT

To evaluate the potential usefulness of 18F-AlF-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in gastrointestinal tumors, and compared with 18F-FDG PET/CT.

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Key information

About this study

Subjects with gastrointestinal tumors underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 18F-AlF-FAPI, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients (aged 18 years or order);
  • patients with suspected or newly diagnosed or previously treated gastrointestinal tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
  • patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans;
  • patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion criteria

  • patients with non-malignant lesions;
  • patients with pregnancy;
  • the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Treatment and study plan

18F-FDG, 18F-AlF-FAPI PET/CT

Diagnostic Test

Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time.

Primary outcomes

  1. Diagnostic accuracy

    Time frame: 30 days

    The sensitivity, specificity, and accuracy of 18F-FDG and 18F-AlF-FAPI PET/CT were calculated and compared to evaluate the diagnostic efficacy.

Secondary outcomes

  1. SUV

    Time frame: 7 days

    Standardized uptake value (SUV) of 18F-FDG and 18F-AlF-FAPI PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.

  2. Number of lesions

    Time frame: 7 days

    The numbers of positive primary and metastatic lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2022
Registry last updated
Aug 1, 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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