Cancer of Unknown Primary Site
Conditions
Brief summary
This study aims to evaluate the diagnostic efficacy, therapeutic assessment, prognostic analysis, and impact on clinical treatment decisions of 18F-FAPI PET/CT in patients with cancer of unknown primary.
Detailed description
Primary endpoint: Diagnostic efficacy of 18F-FAPI PET/CT in patients with undetermined primary tumor (sensitivity, specificity, accuracy). secondary end points: * The diagnostic performance of 18F-FAPI PET/CT compared with CT, MR and 18F-FDG PET in the clinical application of cancer with unknown primary site was compared. ④Assess the heterogeneity of sensitivity and specificity of 18F-FAPI PET/CT for different system sites (neck/thorax/abdomen). * Study on efficacy evaluation and prognostic prediction of 18F-FAPI PET/CT in patients with primary tumors of unknown origin.
Interventions
DIAGNOSTIC_TEST18F-FAPI PET
18F-FAPI-04 PET/CT
Sponsors
First Affiliated Hospital of Zhejiang University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with clinical or imaging suspicion of cancer of unknown primary origin. 2. Patients with 18F FAPI PET scans.
Exclusion criteria
1. Concurrent presence of other active malignant tumors or a history of other malignant tumors within the past 5 years; 2. Severe uncontrollable diseases or active infections; 3. Ineligible participants for project informed consent. 4. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic efficacy | through study completion, an average of 1.5 year | Sensitivity, specificity, positive and negative predictive value of 18F-FAPI PET/CT Imaging in cancers of unknown primary site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standard uptake value （SUV）of tumor | through study completion, 3-4 years | This measure evaluates the association between baseline 18F-FAPI PET parameters (e.g., SUVmax, SUVmean). |
| Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor | through study completion, 3-4 years | This measure evaluates the association between baseline 18F-FAPI PET parameters (MTV in cm3, TLG in cm3\*SUV） |
| Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients | through study completion, 3-4 years | Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients |
Countries
China
Contacts
CONTACTDonghe Chen, MD
Outcome results
None listed