Patients with suspected malignant tumors not diagnosed by other methods
Conditions
Interventions
Index test:[18F]AlF-RESCA-T4 or [68Ga]Ga-NOTA-T4 PET/CT imaging
Sponsors
PEKING UNIVERSITY SHENZHEN HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Subjects will voluntarily participate in this trial and sign an informed consent form. 2) Age >= 18 years and <= 80 years (based on the date of signing the informed consent), gender is not limited. 3) Patients with suspected or newly diagnosed or previously treated malignancies (supporting evidence may include MRI, CT, tumor markers and pathology reports). (supporting evidence may include MRI, CT, tumor markers and pathology reports). 4) Physical fitness score 0-1. 5) Expected survival time greater than 12 weeks. 6) Willingness and ability to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other experimental procedures.
Exclusion criteria
Exclusion criteria: 1. Patients in critical condition requiring emergency treatment; those with severe respiratory failure or airway obstruction due to respiratory diseases; 2. There are contraindications for PET/CT scanning. This includes but is not limited to the inability to lie flat or remain still during PET scanning, intolerance to PET scanning, uncontrolled hyperglycemia; women who are planning to become pregnant, are pregnant, or are nursing; individuals with known allergies to radioactive drugs or their excipients (including a history of severe allergies or allergic reactions, especially to the drugs being tested). 3. Patients who cannot tolerate or have failed to successfully complete the preliminary clinical examinations. 4. Individuals who have previously used radioactive isotopes and the time elapsed since the last administration is less than 10 physical half-lives. 5. Subjects who are currently participating in or planning to participate in any drug or device clinical trials during the study period. 6.Subjects with abnormalities in physical examinations, ECG, and clinical laboratory tests during the screening period, as determined by the investigator, which may affect safety or compliance. 7.Subjects deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy;Sensitivity;Specificity; | — |
Countries
China
Contacts
Public ContactHaibo Chen
PEKING UNIVERSITY SHENZHEN HOSPITAL
Outcome results
None listed