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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cerebral Gliosis, Positron Emission Tomography

Intervention / Treatment
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* Radiation: [18F]BF3-BPA Injection for PET Imaging


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-dose group<br>Subjects in this group were injected intravenously with 5 ± 1 mCi [18F]BF3-BPA | Radiation: [18F]BF3-BPA Injection for PET Imaging<br>* Two dosing dose groups were designed, 5±1 mCi or 9±1 mCi, with 20 subjects in each dose group, and the high dose group study was conducted after enrollment in the low dose group was completed.<br>|
| Experimental: High-dose group<br>Subjects in this group were injected intravenously with 9 ± 1 mCi [18F]BF3-BPA | Radiation: [18F]BF3-BPA Injection for PET Imaging<br>* Two dosing dose groups were designed, 5±1 mCi or 9±1 mCi, with 20 subjects in each dose group, and the high dose group study was conducted after enrollment in the low dose group was completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete PET imaging | To evaluate the biodistribution characteristics (SUVmax, SUVmean) of PET imaging with different doses of [18F]BF3-BPA in brain tumor/normal brain tissues of patients with suspected gliomas, and to obtain the optimal imaging time and optimal dose of [18F]BF3-BPA PET imaging in patients with suspected gliomas. | 90mins from time of injection |