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

Launched by HUASHAN HOSPITAL · Nov 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a special imaging method called \[18F\]BF3-BPA PET imaging to help doctors better see and understand brain tumors known as gliomas. Gliomas can be either high-grade (more aggressive) or low-grade (less aggressive), and the goal of this study is to see how well this new tracer binds to these tumors in the brain. The researchers want to find out if \[18F\]BF3-BPA can improve the diagnosis of gliomas and help differentiate between different types of these tumors. They will also assess how safe and tolerable this imaging technique is for patients.

To participate in the trial, you need to be at least 18 years old and have a suspected brain glioma that hasn’t been treated with surgery, radiation, or other invasive procedures. You should also be in generally good health and able to undergo MRI and PET scans. If you choose to join, you will receive more information about the study, and you will need to give your consent to participate. This study could provide valuable insights into better diagnosing and treating gliomas, which can ultimately help improve patient care.

Gender

ALL

Eligibility criteria

• 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;