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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose group | Experimental | Subjects in this group were injected intravenously with 5 ± 1 mCi [18F]BF3-BPA |
|
| High-dose group | Experimental | Subjects in this group were injected intravenously with 9 ± 1 mCi [18F]BF3-BPA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]BF3-BPA Injection for PET Imaging | Radiation | 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. |
| 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 |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yihui Guan, MD | Contact | +8613764308300 | guanyihui@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Xie, PhD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | 200040 | China |
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| ID | Term |
|---|---|
| D005911 | Gliosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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