Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04420702 | RECRUITING | Prostate Cancer

Diffusion Basis Spectrum Imaging of the Prostate
Sponsor:

Washington University School of Medicine

Brief Summary:

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.

Condition or disease

Prostate Cancer

Intervention/treatment

MRI with DBSI analysis

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 500 participants
Masking : SINGLE
Masking Description : -Dr. Kim will be blinded to the DBSI results at the time of biopsy, but will have the conventional MRI interpretation available
Primary Purpose : DIAGNOSTIC
Official Title : Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer
Actual Study Start Date : 2020-02-27
Estimated Primary Completion Date : 2027-05-31
Estimated Study Completion Date : 2027-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
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)
Diffusion Basis Spectrum Imaging of the Prostate

Location Details

NCT04420702

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Missouri

Washington University School of Medicine

St Louis, Missouri, United States, 63110