Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/CT in Patients With Gastrointestinal Tumors and Compared With 18F-FDG PET/CT
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 18F-AlF-FAPI PET/CT Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time. |
Diagnostic Test: 18F-FDG, 18F-AlF-FAPI PET/CT
Each subject receives a single intravenous injection of 18F-FDG and 18F-AlF-FAPI, and undergo PET/CT imaging within the specified time.
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Outcome Measures
Primary Outcome Measures
- Diagnostic accuracy [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 Outcome Measures
- SUV [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.
- Number of lesions [7 days]
The numbers of positive primary and metastatic lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation.
Eligibility Criteria
Criteria
Inclusion Criteria:
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adult patients (aged 18 years or order);
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patients with suspected or newly diagnosed or previously treated gastrointestinal tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
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patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans;
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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:
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patients with non-malignant lesions;
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patients with pregnancy;
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the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | The First affiliated hospital of xiamen university | Xiamen | Fujian | China | 361000 |
Sponsors and Collaborators
- The First Affiliated Hospital of Xiamen University
Investigators
- Study Chair: Long Sun, PhD, The First Affiliated Hospital of Xiamen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XMYY-2021KY061