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.
Written and voluntarily given Informed Consent.
Male or female ≥18 years of age at time of consent.
Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
Have any serious non-malignant disease (e.g., psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or with the safety or compliance of the participant, as judged by the Investigator.
Have a mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study.
Be a female who is pregnant or breastfeeding.
Single group
18F-T2 PET/CT
Diagnostic test18F-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.
The 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.
Incidence of Adverse Events [Safety and Tolerability]
Safety of administration of 18F-T2, according to Common Terminology Criteria for Adverse Events (CTCAE v6.0).
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
