The study systematically evaluates the diagnostic performance of FAPI-RuiJ and FAPI-04 PET/CT or PET/MR in various solid tumor types, and is expected to provide a novel molecular imaging tool for early lesion detection, accurate staging, and recurrence surveillance in patients with solid tumors.
This prospective study is designed to evaluate and compare the PET/CT or PET/MR imaging characteristics of two fibroblast activation protein (FAP)-targeted tracers-the novel tracer FAPI-RuiJ and the reference tracer FAPI-04-across a diverse range of solid tumors. All enrolled patients will undergo paired PET imaging with both FAPI-RuiJ and FAPI-04. For each tracer, semi-quantitative uptake parameters (including SUVmax, SUVmean, SUVpeak, tumor-to-background ratio \[TBR\]）will be measured and compared. Biodistribution characteristics of FAPI-RuiJ in normal organs will be assessed to determine its in vivo metabolic profile. Using histopathology or imaging follow-up as the reference standard, the diagnostic performance of FAPI-RuiJ PET will be compared with that of FAPI-04 PET, with evaluation metrics including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and area under the receiver operating characteristic curve (AUC). Correlation analyses will be performed between PET parameters and clinicopathological characteristics, including tumor markers, pathological subtype, and immunohistochemical markers.The study is expected to provide a novel molecular imaging tool to support early lesion detection, accurate staging, and recurrence surveillance in patients with solid tumors.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
200
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGDiagnostic sensitivity, specificity, PPV, NPV, and accuracy of FAPI-RuiJ PET versus FAPI-04 PET
Overall and tumor type-specific diagnostic performance in solid tumors, using histopathology or imaging follow-up as the reference standard.
Time frame: Through study completion, an average of 3 years
AUC of FAPI-RuiJ PET versus FAPI-04 PET
Overall and tumor type-specific AUC comparison between the two tracers in solid tumors, using histopathology or imaging follow-up as the reference standard.
Time frame: Through study completion, an average of 3 years
Comparison of SUVmax, SUVmean, and SUVpeak of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions
Semi-quantitative comparison of standardized uptake value (SUV) parameters (SUVmax, SUVmean, and SUVpeak) between the two tracers in solid tumor lesions.
Time frame: At the time of PET/CT scan
Comparison of TBR of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions
Semi-quantitative comparison of TBR between the two tracers in solid tumor lesions. TBR is calculated as the ratio of tumor SUVmax to background SUVmean.
Time frame: At the time of PET/CT scan
Biodistribution characteristics of FAPI-RuiJ PET in normal organs
Quantitative assessment of FAPI-RuiJ tracer biodistribution in major normal organs (including brain, submandibular gland, thyroid, lung, descending aorta, heart, liver, pancreas, stomach, spleen, kidney, bone, muscle, small intestine, gallbladder) measured by SUVmean and SUVmax on PET/CT images using ROI-based analysis.
Time frame: At the time of PET/CT scan
Correlation between FAPI-RuiJ PET semi-quantitative parameters and clinicopathological characteristics in solid tumors
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Correlation analysis between FAPI-RuiJ PET semi-quantitative uptake parameters (including SUVmax, SUVmean, SUVpeak, TBR and clinicopathological characteristics, including tumor markers (e.g., CEA, CA19-9, AFP, etc.), pathological subtype, and immunohistochemical markers (e.g., Ki-67, PD-L1, EGFR, etc.). Correlations will be assessed using Spearman's rank correlation coefficient (ρ), with statistical significance set at p \< 0.05.
Time frame: Through study completion, an average of 3 years