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

Sponsor

Huashan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06148207

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Gliosis Positron Emission Tomography	Radiation: [18F]BF3-BPA Injection for PET Imaging	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jun 13, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low-dose group Subjects in this group were injected intravenously with 5 ± 1 mCi [18F]BF3-BPA	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.
Experimental: High-dose group Subjects in this group were injected intravenously with 9 ± 1 mCi [18F]BF3-BPA	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.

Arm

Intervention/Treatment

Experimental: Low-dose group

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

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.

Experimental: High-dose group

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

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

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:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huashan Hospital	Shanghai		China	200040

Sponsors and Collaborators

Huashan Hospital

Investigators

Principal Investigator: Fang Xie, PhD, Huashan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

YiHui Guan, Professor, Huashan Hospital

ClinicalTrials.gov Identifier:

NCT06148207

Other Study ID Numbers:

KY2023-778

First Posted:

Nov 28, 2023

Last Update Posted:

Nov 28, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gliosis

Study Results

No Results Posted as of Nov 28, 2023