Diffusion Basis Spectrum Imaging of the Prostate

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT04420702
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MRI with DBSI analysis — DEVICE
    -The procedure will take approximately 1 hour of the participant's time

Study Details

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.

Key Dates

Start date
Feb 27, 2020
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Early Detection Cohort (MRI with DBSI)
    * Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy * Standard of care prostate biopsy will be performed within 12 weeks of MRI * Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging
  • Experimental: Active Surveillance Cohort (MRI with DBSI)
    * Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy * Standard of care prostate biopsy will be performed within 12 weeks of MRI * Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging

Primary Outcome Measure

Area under the curve (AUC) comparison from biopsy and DBSI [ Time Frame: Up to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Joseph Ippolito, M.D.
[email protected]
314-362-2928
Alex Kim
[email protected]
314-747-9781
Joseph Ippolito, M.D. (PRINCIPAL_INVESTIGATOR)
Sheng-Kwei Song, Ph.D. (SUB_INVESTIGATOR)
Michael H Johnson, M.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Washington University School of Medicine· St Louis, MO

Related Studies