Overview
In this clinical study, we proposed to perform [18F]BF3-BPA PET imaging in subjects with gliomas, to observe the binding ability and non-specific binding of the tracer to glioma lesions in vivo, and at the same time to evaluate the effectiveness of [18F]BF3-BPA in the diagnosis and differential diagnosis of glioma, and to evaluate the tolerability and safety of the tracer and the imaging method. The efficacy of [18F]BF3-BPA in the diagnosis and differential diagnosis of gliomas will be evaluated, as well as the tolerability and safety of this tracer and imaging method.
This study will provide a new method for in vivo imaging of gliomas and provide a clear and intuitive imaging basis for clinical diagnosis, differential diagnosis and treatment.
Eligibility
Inclusion Criteria:
- 1. Patients with suspicious brain gliomas:
- Patients diagnosed by the investigator, based on symptoms, course of disease, and MRI of the head, as having a suspected high- or low-grade brain glioma, scheduled for brain tumor resection, and with no contraindications to surgery;
- No prior and/or current surgery, radiotherapy, or puncture biopsy (other than treatment for symptomatic relief) for brain tumors;
- No other primary malignant tumor. 2. age ≥ 18 years; 3. Eastern Cooperative Oncology Group (ECOG) 0-2; 4. adequate organ function:
- Platelet count >100 x 109/L;
- Urea/urea nitrogen and serum creatinine <1.5 times upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times ULN. 5. Subjects should be fully informed of the content, process and possible risks of the test and voluntarily sign an informed consent form.
Exclusion Criteria:
- Subjects meeting any of the following criteria will be excluded from the study:
- Severe allergic reaction to any of the drugs or their components in this trial;
- Those who cannot tolerate or are contraindicated to undergo MRI and PET;
- Those who cannot accept or tolerate blood sample collection;
- Those who are unable to use effective contraception from the date of signing the informed consent to 3 months after the administration of the drug;
- pregnant or lactating women or those with positive blood pregnancy test results;
- Those who have participated in other interventional clinical trials prior to the date of informed consent and are within 5 half-lives of the trial drug, or are participating in other interventional clinical trials;