Diffusion Basis Spectrum Imaging of the Prostate
Recruiting · NCT04420702 · Interventional (participants receive a specific treatment) · Lead sponsor: Washington University School of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
MRI with DBSI analysis
What this trial is about
Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Over 18 years of age and willing and able to provide informed consent.
- Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort")
- Including those men with:
- an elevated PSA and no prior biopsy
- an elevated PSA and a negative prior biopsy
- Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort")
Exclusion criteria
- Patients with any clinical contraindication to MRI
- \*Including but not limited to:
- Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators
- Those with cochlear implants
- Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate)
- Those who cannot lie flat for over 1 hour
- Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)
Where it is running
1 location listed across 1 US state.
- Washington University School of Medicine - St Louis, Missouri, United States