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

NCT ID: NCT06148207

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-09-01

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.

Conditions

Cerebral Gliosis; Positron Emission Tomography

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Low-dose group

Subjects in this group were injected intravenously with 5 ± 1 mCi \[18F\]BF3-BPA

Group Type: EXPERIMENTAL

[18F]BF3-BPA Injection for PET Imaging

Intervention Type: 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.

High-dose group

Subjects in this group were injected intravenously with 9 ± 1 mCi \[18F\]BF3-BPA

Group Type: EXPERIMENTAL

[18F]BF3-BPA Injection for PET Imaging

Intervention Type: 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.

Interventions

[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.

Intervention Type: RADIATION

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

YiHui Guan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fang Xie, PhD

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital

Locations

Huashan Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yihui Guan, MD

Role: CONTACT

guanyihui@hotmail.com

+8613764308300

Facility Contacts

Yihui Guan, MD

Role: primary

guanyihui@hotmail.com

+8613764308300

Other Identifiers

KY2023-778

Identifier Type: -

Identifier Source: org_study_id