The goal of this clinical trial is to evaluate the diagnostic value of CAIX protein specific probe 18F-T2 in PET/CT imaging in participants with solid tumors. It will also assess the safety, tolerability and radiation dosimetry of 18F-T2.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
18F-T2 is injected intravenously with a dose of 0.05-0.10 mCi/kg. The CT and PET imaging session will begin approximately 60 minutes after 18F-T2 administration.
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe Diagnostic Sensitivity and Specificity of 18F-T2 PET/CT in the Evaluation of CAIX Positive Solid Tumors
The diagnostic performance of 18F-T2 PET/CT and 18F-FDG PET/CT for staging will be evaluated and compared, using histopathological findings as the gold standard or, if not available, follow-up clinical and conventional imaging examinations (ultrasound, CT, or MRI) for at least 3 months as the reference standard.
Time frame: From study completion to 1 month after completion
Incidence of Adverse Events [Safety and Tolerability]
Safety of administration of 18F-T2, according to Common Terminology Criteria for Adverse Events (CTCAE v6.0).
Time frame: 24 hours after the injection of 18F-T2
Maximum Standardized Uptake Value [SUVmax] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT
Comparison of maximum standardized uptake value (SUVmax) of primary and metastatic lesions between 18F-T2 PET/CT and 18F-FDG PET/CT.
Time frame: From study completion to 1 month after completion
Mean Standardized Uptake Value [SUVmean] of Primary and Metastatic Lesions on 18F-T2 PET/CT vs. 18F-FDG PET/CT
Comparison of mean standardized uptake value (SUVmean) of primary and metastatic lesions between 18F-T2 PET/CT and 18F-FDG PET/CT.
Time frame: From study completion to 1 month after completion
Correlation between T2 Uptake and CAIX Pathological Expression
Evaluation of the correlation between uptake parameters derived from 18F-T2 PET/CT and CAIX expression level measured by immunohistochemistry (IHC) in tumor tissue samples.
Time frame: From study completion to 1 month after completion
Dosimetry of 18F-T2
Research on the dose distribution of 18F-T2 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software.
Time frame: From study completion to 1 month after completion
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