18F-FAPI PET in Cancers of Unknown Primary Site
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-FAPI PET.
- Who it may be relevant to
- Registry conditions: Cancer of Unknown Primary Site. Basic parameters: 20 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Clinical Study and Exploration of 18F-FAPI PET/CT Imaging in Cancers of Unknown Primary Site
Overview
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 test 18F-FAPI PET
18F-FAPI-04 PET/CT
Primary outcome measures
- Diagnostic efficacy [Time frame: through study completion, an average of 1.5 year]
Secondary outcome measures (3)
- Standard uptake value （SUV）of tumor [Time frame: through study completion, 3-4 years]
- Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor [Time frame: through study completion, 3-4 years]
- Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients [Time frame: through study completion, 3-4 years]
Eligibility criteria
Inclusion criteria
- Patients with clinical or imaging suspicion of cancer of unknown primary origin.
- Patients with 18F FAPI PET scans.
Exclusion criteria
- Concurrent presence of other active malignant tumors or a history of other malignant tumors within the past 5 years;
- Severe uncontrollable diseases or active infections;
- Ineligible participants for project informed consent.
- Pregnant and lactating women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07372963 · FirstZhejiangU-FAPI-CUPs