Adding targeted covalent radiopharmaceutical (TCR) moiety to fibroblast activation protein inhibitor (FAPI) can increase tumor uptake and tumor retention in pre-clinical studies. This study is an open-labeled single-arm phase II diagnostic clinical trial to explore the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumor patients.
TCR-FAPI can covalently bind to FAP that increase tumor uptake and tumor retention in pre-clinical studies, which elevates the ability for cancer imaging and facilitates the targeted radionuclide therapy. This study is an open-labeled single-arm phase II diagnostic clinical trial to explore the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumor patients. Quantitative features (i.e., SUVmax) will be calculated to evaluate the PET images. Alternative imaging modality, including but not limited to, Ultrasound, CT, MRI, and PET/CT with other radiotracers, might be applied according to clinical needs. For patients who took surgery after multiple examination, tumor tissue and histopathology will also be obtained. For patients who underwent other treatment, treatment response of each individual lesion will be observed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
A dose of 3.7 MBq/kg 68Ga-TCR-FAPI will be intravenously injected and PET examination will be carried out within the specified time.
Peking University Cancer Hospital
Beijing, China
RECRUITINGDiagnostic accuracy
The sensitivity, specificity, and accuracy of 68Ga-TCR-FAPI PET/CT to detect tumor lesions were calculated to evaluate the diagnostic efficacy.
Time frame: 90 days
Tumor uptake
The standardized uptake value (SUV) of lesions were calculated.
Time frame: 90days
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