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

Positron Emission Tomography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06148207
• Other study ID #: KY2023-778
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: November 2023
• Source: Huashan Hospital
• Contact: Yihui Guan, MD
• Phone: +8613764308300
• Email: guanyihui[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 1, 2025
• Est. primary completion date: June 13, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Gliosis
• Positron Emission Tomography

Intervention

Radiation:
• [18F]BF3-BPA Injection for PET Imaging
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.

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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