glioma
Conditions
Interventions
Test group:Perform 68Ga-EGFRvIII PET imaging for the patients with glioma
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 and above), regardless of gender. 2. For the first treatment of glioma cases, this study intends to initially recruit 20 cases of clinically suspected high-grade primary glioblastoma that have not received treatment for research and analysis. 3. Patients who can provide informed consent (if the individual has the capacity to consent, they should sign the informed consent form themselves; if the individual does not have the capacity to consent, the participant, family member, or legal representative should sign) and agree in accordance with the guidelines of the clinical research ethics committee. 4. Blood test: white blood cell count (WBC) 4~10×10^9/L; platelet (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 the normal range. 6. Liver function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range. 7. Electrocardiogram: no significant abnormalities. 8. Patients of childbearing age are willing to cooperate with contraception.
Exclusion criteria
Exclusion criteria: 1. Potential subjects have contraindications for PET/CT scans. These include but are not limited to uncontrolled hyperglycemia; pregnant, lactating or postpartum women; those unable to tolerate repeated intravenous injections; those with possible allergies to the drug and its components (including a history of severe allergies or allergic reactions, especially to the drug under investigation); and those with claustrophobia. 2. Within the past year, the potential subject has participated in other research protocols or clinical care that would result in radiation exposure exceeding 50 mSv of effective dose, in addition to the expected radiation exposure from this clinical study. 3. The potential subject has the following difficult-to-control clinical conditions: including but not limited to systemic diseases such as coronary artery disease, heart failure, unstable angina or arrhythmia, uremia, liver failure, acute stroke, acute myocardial infarction, unstable diabetes; a history of head injury or intracranial surgery; hypoxia, sepsis or severe infectious diseases; mental disorders, epilepsy and severe depression or a history of these; and a positive test history for human immunodeficiency virus (HIV). 4. The potential subject has significant abnormalities in laboratory tests that are clinically considered to be significant or unstable. 5. Drug abuse or alcoholism for at least 3 months. 6. The potential subject has any clinical condition that the study principal investigator believes may be caused or potentially harmful by the study drug. 7. Possible allergy to components of the 68Ga-EGFRvIII injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SUVmax of tumor;SUVmean of tumor;SUVmean of healthy brain area;Tumor/Background ratio;time activity curve; | — |
Countries
China
Contacts
Public ContactGuan Yihui
Huashan Hospital, Fudan University
Outcome results
None listed