Solid Tumor
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTFAPI-RuiJ
A novel FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously.
DIAGNOSTIC_TESTFAPI-04
A FAP-targeted radiotracer for PET/CT or PET/MR imaging; administered intravenously.
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years and ≤ 80 years, regardless of gender. 2. Participants with suspected, confirmed, or suspected recurrent solid tumors. 3. Participants who agree to participate in this clinical trial and provide written informed consent. 4. Participants with good compliance, who commit to adhering to the study procedures and cooperate with the full study process. 5. No plans for pregnancy within 6 months.
Exclusion criteria
1. Patients with severe medical conditions that, in the investigator's opinion, make them unsuitable for participation in this clinical study, including but not limited to: severe cardiopulmonary insufficiency, severe bone marrow suppression, and severe hepatic or renal insufficiency. 2. Patients with claustrophobia, severe psychiatric symptoms, or impaired consciousness that precludes cooperation with the examination procedures. 3. Patients who have received any anti-tumor therapy during the interval between the two PET imaging sessions. 4. Pregnant or breastfeeding women. 5. Patients with poor compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic sensitivity, specificity, PPV, NPV, and accuracy of FAPI-RuiJ PET versus FAPI-04 PET | Through study completion, an average of 3 years | Overall and tumor type-specific diagnostic performance in solid tumors, using histopathology or imaging follow-up as the reference standard. |
| AUC of FAPI-RuiJ PET versus FAPI-04 PET | Through study completion, an average of 3 years | Overall and tumor type-specific AUC comparison between the two tracers in solid tumors, using histopathology or imaging follow-up as the reference standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of SUVmax, SUVmean, and SUVpeak of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions | At the time of PET/CT scan | Semi-quantitative comparison of standardized uptake value (SUV) parameters (SUVmax, SUVmean, and SUVpeak) between the two tracers in solid tumor lesions. |
| Comparison of TBR of FAPI-RuiJ PET versus FAPI-04 PET in solid tumor lesions | At the time of PET/CT scan | 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. |
| Biodistribution characteristics of FAPI-RuiJ PET in normal organs | At the time of PET/CT scan | 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. |
| Correlation between FAPI-RuiJ PET semi-quantitative parameters and clinicopathological characteristics in solid tumors | Through study completion, an average of 3 years | 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. |
Countries
China
Contacts
CONTACTYing Miao
PRINCIPAL_INVESTIGATORBiao Li
Ruijin Hospital
Outcome results
None listed