Comaprison of 68Ga-FAP-2286 and 18F-FDG PET/CT in Patients With Various Types of Cancer
Study Details
Study Description
Brief Summary
To evaluate the potential usefulness of 68Ga-FAP-2286 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, and compared with 18F-FDG PET/CT.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
Subjects with various types of cancer underwent contemporaneous 68Ga-FAP-2286 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 68Ga-FAP-2286 PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 68Ga-FAP-2286, 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: 68Ga-FAP-2286 Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-2286, and undergo PET/CT imaging within the specified time. |
Diagnostic Test: 18F-FDG
Each subject receives a single intravenous injection of 18F-FDG and 68Ga-FAP-2286, and undergo PET/CT imaging within the specified time. A part of participants will also undergo additional 68Ga-FAPI-46 PET/CT for comparison.
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Outcome Measures
Primary Outcome Measures
- Diagnostic accuracy [90 days]
The sensitivity, specificity, and accuracy of 18F-FDG and 68Ga-FAP-2286 PET/CT were calculated and compared to evaluate the diagnostic efficacy.
Secondary Outcome Measures
- Standardized uptake value (SUV) [30 days]
Standardized uptake value (SUV) of 18F-FDG and 68Ga-FAP-2286 PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.
- Number of lesions [90 days]
The numbers of positive primary and metastatic lesions of 18F-FDG and 68Ga-FAP-2286 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 malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
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patients who had scheduled both 18F-FDG and 68Ga-FAP-2286 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 Director: Long Sun, PhD, The First Affiliated Hospital of Xiamen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022KY013