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

Not Applicable

Recruiting

• Conditions: Positron Emission Tomography; Cerebral Gliosis
• Interventions: Radiation: [18F]BF3-BPA Injection for PET Imaging

• Registration Number: NCT06148207
• Lead Sponsor: Huashan Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-19
• Study First Submitted QC: 2023-11-19
• Last Update Submitted: 2023-11-19
• Study First Posted: 2023-11-28
• Last Update Posted: 2023-11-28
• Primary Completion: 2025-06-13
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low-dose group	[18F]BF3-BPA Injection for PET Imaging	Subjects in this group were injected intravenously with 5 ± 1 mCi \[18F\]BF3-BPA
High-dose group	[18F]BF3-BPA Injection for PET Imaging	Subjects in this group were injected intravenously with 9 ± 1 mCi \[18F\]BF3-BPA

Primary Outcome Measures

Name	Time	Method
Complete PET imaging	90mins from time of injection	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.

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, China