Glioma
Conditions
Interventions
Gold Standard:?Pathological findings of tumor tissue specimens obtained by targeting hotspots (areas with elevated SUV values) on 18F-AG881 PET imaging under multimodal navigation guidance.
Index test:?1. Safety Endpoints: Absence of any patient-reported adverse events or objective abnormalities in laboratory parameters.
?2. Diagnostic Efficacy Metrics:
(1) ?Tracer Uptake Kinetics:
- Mea
- Tumor-to-background ratio (TBR)
- Time-to-peak uptake
- Area under the time-activity curve (AUC-TAC).
(2) ?Molecular Imaging Validation:
- Multimodal image co-registration of 18F-AG881 PET/CT with structural MRI and functional MRI (resting-state BOLD, DT
- Multimodal navigation-guided biopsy targeting hotspots (regions with elevated SUV on 18F-AG881 PET)
- Pathological analysis of obtained high-grade glioma specimens
- Statistical correlation between semi-quantitative imaging parameters (e.g., SUVmax, TBR) and molecular pathology results (IDH mutation status) to validate noninvasive prediction accuracy.
Sponsors
Fudan University Affiliated Huashan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Adult patients (18 years old and above) of both sexes. (2) For the first treatment of glioma cases, this study initially recruited 10 untreated patients with clinically suspected high-grade primary glioblastomas for study and analysis, and the patients agreed to undergo surgical treatment or tissue biopsy (3) Able to provide informed consent (if I have the ability to consent, I should sign the informed consent; Without capacity for informed consent, signed by the participant, family member or legal representative) and in accordance with the guidelines of the Clinical Research Ethics Committee. (4) An Eastern Cooperative Oncology Group (ECOG) performance score between 0-2 and at least one lesion with a maximum diameter greater than 1 cm (according to RECIST, version 1.1) in the brain. (5) Blood routine: white blood cell count (WBC) 4-10 ×109/L; Platelet (PLT) 100-300 ×109/L; Hemoglobin (HB) was 120-160 g/L. (6) Renal function: serum creatinine less than or equal to the upper limit of the normal range. (7) Liver function: bilirubin, AST(SGOT)/ALT(SGPT) were less than or equal to the upper limit of the normal range. (8) Electrocardiogram: no significant abnormality. (9) Patients of childbearing age can cooperate with contraception.
Exclusion criteria
Exclusion criteria: (1) PET/CT scan was contraindicated in the alternative study participants. Including, but not limited to, uncontrolled elevated blood glucose; Pregnant, lactating or lactating women; Unable to receive repeated intravenous injections; Persons with possible allergy to the drug or its components (including a history of severe allergy or anaphylaxis, particularly to the tested drug); Claustrophobia. (2) In the past year, in addition to the radiation exposure expected from participation in this clinical study, participation in other research protocols or clinical care resulted in radiation exposure exceeding an effective dose of 50 mSv. (3) Candidate study participants had the following clinical conditions that were difficult to control, including but not limited to systemic diseases including coronary artery disease, heart failure, unstable angina or arrhythmia, uremia, liver failure, sudden stroke, acute myocardial infarction, or unstable diabetes. Previous head injury, intracranial surgery; Hypoxia, sepsis or severe infectious diseases; A history of mental disorders, epilepsy and major depression; Human immunodeficiency virus (HIV) positive test history. (4) Participants in the alternative study had significant abnormalities in laboratory tests that were considered clinically significant or unstable. (5) Drug abuse or alcohol abuse for at least 3 months; (6) The alternative study participant had any clinical condition that the study chair considered to be potentially harmful due to the preparation. (7) May be allergic to components of 18F-AG881 injection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized uptake value ratio ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average radioactive concentration within the tumor;Maximum voxel concentration within the tumor;Tumor/non tumor radioactive concentration ratio;Peak time of radioactive uptake;Area under the radioactive activity time curve; | — |
Countries
China
Contacts
Public ContactYihui Guan
Fudan University Affiliated Huashan Hospital
Outcome results
None listed