[18F]BF3-BPA Injection for PET Imaging Study of Gliomas in the Brain

[18F]BF3-BPA Injection for PET Imaging Study of Gliomas in the Brain

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.

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:

  1. Severe allergic reaction to any of the drugs or their components in this trial;
  2. Those who cannot tolerate or are contraindicated to undergo MRI and PET;
  3. Those who cannot accept or tolerate blood sample collection;
  4. 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;
  5. pregnant or lactating women or those with positive blood pregnancy test results;
  6. 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;