Using BBPA PET/CT to Diagnose Malignant Tumors
Safety and Clinical Value of 18Fluorine-labeled BBPA PET/CT in Patients With Malignant Tumors
This study is testing a new imaging method using BBPA to see if it can help doctors better detect malignant brain tumors in patients who might have them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05987098 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and diagnostic value of BBPA-PET/CT imaging in patients suspected of having malignant tumors. The study focuses on utilizing BBPA, a novel boron amino acid, to enhance the detection of brain tumors through advanced imaging techniques. Patients will undergo PET imaging, and those who require surgery will have their tumor characteristics analyzed through histopathology and molecular pathology. The trial aims to establish the clinical utility of BBPA in identifying malignant tumors and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with suspected brain tumors based on clinical and imaging evaluations.
Not a fit: Patients with contraindications for PET-CT imaging or those in critical health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses of malignant tumors, potentially improving treatment outcomes.
How similar studies have performed: Preliminary studies have suggested the potential of BBPA as a diagnostic tool, but further clinical evidence is needed to confirm its effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have suspected diagnosis of brain tumors, based on clinical performance and imaging results. * Meet the indications for PET examination, show a clear indication and no contraindications; * Have a performance status of score ≥80 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation; * Does not appear agonal stage, deep coma, over grade 2 major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection; * Be ≥ 18 years of age on day of signing informed consent. * Be willing and able to understand the research content and provide written informed consent/assent for the trial. Exclusion Criteria: * Have a history of imaging agent allergies; * Does not meet the PET-CT scan sedation requirements, or there are contraindications for PET-CT examination; * Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial; * Unable to adhere strictly to protocol requirements.
Where this trial is running
Beijing, Beijing
- Wenbin Ma — Beijing, Beijing, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.