Prostate CancerDiagnostics and screeningProstate healthMen's healthDevice
What this study is
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.
What's being tested
- MRI with DBSI analysis
Intervention · DEVICE
-The procedure will take approximately 1 hour of the participant's time
Study details
- Official title
- Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer
- Sponsor
- Washington University School of Medicine
- Conditions
- Prostate Cancer
- Enrolling
- 500 people
- Starts
- 2020-02-27
- Est. completion
- 2027-05-31
- Design
- Single-blind, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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")
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWashington University School of Medicine
St Louis, Missouri, United States
- Joseph Ippolito, M.D. · Contact314-362-2928ippolitoj@wustl.edu
- Alex Kim · Contact314-747-9781klima@wustl.edu
- Joseph Ippolito, M.D. · Principal investigator
- Sheng-Kwei Song, Ph.D. · Sub-investigator
- Michael H Johnson, M.D. · Sub-investigator
Recruiting
Study team
Sponsor
Washington University School of Medicine
Study ID 201908215
Principal investigator
Joseph Ippolito, M.D.
Washington University School of Medicine
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.