Patients with neuroendocrine tumors (NENs) originating from the gastrointestinal pancreas, lung, neural crest, or with an unknown primary source, who require diagnosis or are suspected.
Conditions
Interventions
Index test:18F-FDG and 18F-SSTRP PET/CT 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 between 18 and 70 years (based on the date of signing the informed consent form), gender is not restricted. 3.The main inclusion criterion is patients with suspected or to-be-diagnosed neuroendocrine tumors (NENs) originating from the gastrointestinal pancreas, lungs, neural crest, or with an unknown primary source. 4.Expected survival time is more than 12 weeks. 5.The blood routine and liver/kidney function meet the following criteria: Blood routine: WBC >= 4.0×10^9/L or neutrophils >= 1.5×10^9/L, PLT >= 100×10^9/L, Hb >= 90g/L; PT or APTT <= 1.5 ULN; Liver/kidney function: T-Bil <= 1.5×ULN (upper limit of normal), ALT/AST <= 2.5 ULN or <= 5×ULN (for patients with liver metastasis), ALP <= 2.5 ULN (or <= 4.5 ULN if bone or liver metastasis is present); BUN <= 1.5×ULN, SCr <= 1.5×ULN. 6.Willing and able to comply with the diagnostic plan, clinical laboratory tests, and other trial procedures.
Exclusion criteria
Exclusion criteria: 1.Critically ill patients; those with severe respiratory failure or airway obstruction caused by respiratory diseases. 2.Conditions with contraindications for PET/CT scans, including but not limited to uncontrolled elevated blood glucose levels; women who are planning pregnancy, pregnant, or breastfeeding; known allergies to radioactive drugs or their excipients (including a history of severe allergies or allergic reactions, particularly to the tested drug). 3.Patients who cannot tolerate or have not successfully completed prior clinical examinations. 4.Patients who have previously used radioactive isotopes and have a time interval of less than 10 physical half-lives from the administration of the study drug. 5.Patients who are currently participating or plan to participate in any drug or device clinical trials during the study. 6.Patients who, in the judgment of the investigator, are considered unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy;Specificity;Sensitivity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive predicative value;Negative predictive value; | — |
Countries
China
Contacts
Public ContactHaibo Chen
PEKING UNIVERSITY SHENZHEN HOSPITAL
Outcome results
None listed