Status:
UNKNOWN
[18F]BF3-BPA Injection for PET Imaging Study of Gliomas in the Brain
Lead Sponsor:
Huashan Hospital
Conditions:
Cerebral Gliosis
Positron Emission Tomography
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06148207
Start Date
September 1 2023
End Date
September 1 2025
Last Update
November 28 2023
Active Locations (1)
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1
Huashan Hospital
Shanghai, China, 200040