High-Grade Gliomas
Conditions
Interventions
Index test:¹¹C-CPPC PET imaging targeting the colony-stimulating factor 1 receptor (CSF1R)
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Adult patients (>=18 years old), regardless of sex. 2.Patients with newly diagnosed, treatment-naïve, clinically suspected High-Grade gliomas intended for initial evaluation; a total of 10 subjects will be enrolled. 3.Ability to provide informed consent (the patient should sign the consent form if capable; otherwise, it should be signed by a legal guardian, family member, or authorized representative, in accordance with ethics committee guidelines). 4.Hematologic parameters within the following ranges: White blood cell count (WBC): 4–10 × 10^9/L; Platelet count (PLT): 100–300 × 10^9?/L; Hemoglobin (HB): 120–160 g/L. 5.Renal function: Serum creatinine less than or equal to the upper limit of normal. 6.Liver function: Total bilirubin, AST (SGOT), and ALT (SGPT) less than or equal to the upper limit of normal. 7.Electrocardiogram (ECG): No significant abnormalities. 8.Women of childbearing age must agree to use effective contraception.
Exclusion criteria
Exclusion criteria: 1.Contraindications to PET/CT scanning, including but not limited to: uncontrolled hyperglycemia, pregnancy or lactation, inability to tolerate repeated intravenous injections, known or suspected allergy to the investigational drug or its components (including a history of severe allergic reactions), or claustrophobia. 2.Participation in other clinical studies or procedures within the past year (excluding this study) that resulted in cumulative radiation exposure exceeding 50 mSv. 3.Presence of uncontrolled clinical conditions, including but not limited to: systemic diseases such as coronary artery disease, heart failure, unstable angina or arrhythmias, uremia, hepatic failure, stroke, acute myocardial infarction, unstable diabetes mellitus; history of head trauma or intracranial surgery; hypoxia, sepsis, or serious infectious diseases; psychiatric disorders, epilepsy, or severe depression; history of HIV infection. 4.Clinically significant abnormalities in laboratory tests that are considered by the investigator to be of major concern or unstable. 5.History of drug abuse or alcoholism for at least 3 months. 6.Any other clinical condition deemed by the investigator to pose potential risks related to the investigational drug. 7.Known or suspected hypersensitivity to any component of the ¹¹C-CPPC injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative parameters of 11C-CPPC PET imaging;The accuracy of non-invasive molecular imaging in predicting the occurrence and progression of glioma cases using 11C-CPPC imaging; | — |
Countries
China
Contacts
Public ContactYihui Guan
Huashan Hospital, Fudan University
Outcome results
None listed