Malignant tumors that have been pathologically diagnosed or are suspected by clinical manifestations and other imaging examinations to require a definitive diagnosis.
Conditions
Interventions
Index test:18F-FDG imaging and FAPI/FDG combined imaging
Sponsors
PEKING UNIVERSITY SHENZHEN HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.The participant voluntarily agrees to participate in the trial and signs an informed consent form. 2. Age range: 18-70 years old (based on the date of signing the informed consent form), gender is not limited. 3. The main inclusion criteria for patients are malignant tumors that have been pathologically diagnosed or are suspected by clinical manifestations and other imaging examinations to require a clear diagnosis. 4. Expected survival time exceeds 12 weeks. 5. Blood routine and liver and kidney function meet the following criteria: WBC >= 4.0 × 10^9L or neutrophil >= 1.5 × 10^9L, PLT >= 100 × 10^9/L, Hb >= 90g/L; PT or APTT <= 1.5ULN; Liver and kidney function: T-Bil <= 1.5 × ULT (upper limit of normal), ALT/AST <= 2.5ULN or <= 5 × ULT (for subjects with liver metastasis), ALP <= 2.5ULN (if there is bone metastasis or liver metastasis, ALP <= 4.5ULN); BUN <= 1.5 × ULT, SCr <= 1.5 × ULT). 6. Willing and able to comply with diagnostic plans, clinical laboratory tests, and other experimental procedures.
Exclusion criteria
Exclusion criteria: 1. Emergency treatment for critically ill patients; Severe respiratory failure or airway obstruction caused by respiratory system diseases. 2.There are contraindications for PET/CT scanning. Including but not limited to uncontrolled blood glucose elevation; Women who are preparing for pregnancy, pregnant or breastfeeding; Individuals who are known to be allergic to radioactive drugs or their excipients (including those with a history of severe allergies or allergic reactions, especially those who are allergic to the tested drug). 3. Patients who cannot tolerate or have not successfully completed preliminary clinical examinations. 4. Previously used radioactive isotopes with an interval of less than 10 physical half lives from the time of administration in this study. 5. Currently conducting or planning to participate in any drug or device clinical trials during the research period. 6. Those who are unwilling to undergo pathological examination or have no pathological diagnostic data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy;Sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactHaibo Chen
PEKING UNIVERSITY SHENZHEN HOSPITAL
Outcome results
None listed