Clinical trial NCT06148207: [18F]BF3-BPA Injection for PET Imaging Study of Gliomas in the Brain
Official title: [18F]BF3-BPA Injection for PET Imaging Study of Gliomas in the Brain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Gliosis
Positron Emission Tomography
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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;

Primary outcomes:
measure: Complete PET imaging
timeFrame: 90mins from time of injection
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Fang Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References: