NCT06148207

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

November 19, 2023

Last Update Submit

November 19, 2023

Conditions

Cerebral GliosisPositron Emission Tomography

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Low-dose group

EXPERIMENTAL

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

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

High-dose group

EXPERIMENTAL

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

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

Interventions

[18F]BF3-BPA Injection for PET ImagingRADIATION

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 groupLow-dose group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huashan Hospital

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Gliosis

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Fang Xie, PhD

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihui Guan, MD

CONTACT

+8613764308300guanyihui@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 19, 2023

First Posted

November 28, 2023

Study Start

September 1, 2023

Primary Completion

June 13, 2025

Study Completion

September 1, 2025

Last Updated

November 28, 2023

Record last verified: 2023-11

Locations

CN(1)