PET imaging of gliomas using [18F]BF3-BPA injection

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

This study is testing a new imaging method using a special tracer to see if it can help doctors better diagnose and understand gliomas in patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06148207 on ClinicalTrials.gov

What this trial studies

This clinical study aims to utilize [18F]BF3-BPA PET imaging to assess the binding ability of the tracer to glioma lesions in vivo. It will evaluate the effectiveness of [18F]BF3-BPA for diagnosing and differentiating gliomas, while also examining the safety and tolerability of the tracer and imaging method. The goal is to establish a new in vivo imaging technique that provides clear imaging for clinical diagnosis and treatment planning of gliomas.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with suspected brain gliomas scheduled for tumor resection.

Not a fit: Patients with prior brain tumor surgeries, radiotherapy, or other primary malignant tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of glioma diagnosis and treatment planning for patients.

How similar studies have performed: Other studies have shown promise in using PET imaging for gliomas, but the specific use of [18F]BF3-BPA is relatively novel.

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;

Where this trial is running

Shanghai

• Huashan Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Fang Xie, PhD — Huashan Hospital
• Study coordinator: Yihui Guan, MD

Conditions Cerebral Gliosis; Positron Emission Tomography