Cerebral GliosisNCT06148207
[18F]BF3-BPA Injection for PET Imaging Study of Gliomas in the Brain
A study testing [18F]BF3-BPA Injection for PET Imaging in people with Cerebral Gliosis and Positron Emission Tomography, run by Huashan Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Gliosis, Positron Emission Tomography
- What is being tested?
- [18F]BF3-BPA Injection for PET Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, 200040
Yihui Guan, MD, +8613764308300, guanyihui@hotmail.com
About this study
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
- Being tested
- [18F]BF3-BPA Injection for PET Imaging
- Medical subject headings
- Gliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[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.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | Subjects in this group were injected intravenously with 5 ± 1 mCi [18F]BF3-BPA Receives: 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 Receives: Radiation: [18F]BF3-BPA Injection for PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90mins from time of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start1 Sep 2023
- Primary completion13 Jun 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral GliosisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiHui Guan, Huashan Hospital
- Investigators
- Fang Xie, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148207
- Sponsor's protocol ID
- KY2023-778
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]BF3-BPA Injection for PET Imaging Study of Gliomas in the Brain
- ClinicalTrials.gov ID
- NCT06148207
- Acronym / sponsor ID
- KY2023-778
- Conditions
- Cerebral Gliosis, Positron Emission Tomography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 13 Jun 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Radiation: [18F]BF3-BPA Injection for PET ImagingSubjects in this group were injected intravenously with 5 ± 1 mCi [18F]BF3-BPA |
| High-dose group | Experimental | Radiation: [18F]BF3-BPA Injection for PET ImagingSubjects in this group were injected intravenously with 9 ± 1 mCi [18F]BF3-BPA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- Subjects meeting any of the following criteria will be excluded from the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]BF3-BPA Injection for PET ImagingTwo 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. | Radiation | High-dose group, Low-dose group |
Primary outcome
Complete PET imaging
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Xie, PhD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]BF3-BPA Injection for PET Imaging in people with Cerebral Gliosis and Positron Emission Tomography, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yihui Guan, MD (+8613764308300, guanyihui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete PET imaging (time frame: 90mins from time of injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.