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RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: MRI with DBSI analysis for Prostate Cancer

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.

Official registry: https://clinicaltrials.gov/study/NCT04420702 · Washington University School of Medicine · enrollment listed as 500

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are MRI with DBSI analysis. The registry lists allocation as randomized. 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.

They plan to enroll about 500 people at St Louis. Taking part typically means using or being fitted with a device plus check-ins.

Official title (unrewritten)

Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer

Interventions: MRI with DBSI analysis

Primary outcome (registry wording): Area under the curve (AUC) comparison from biopsy and DBSI

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Men only
  • 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")

Public study contact (from the registry)

Hongyu An, M.D., Ph.D.

314-362-5805

hongyuan@wustl.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

FAQ about this NCT record

Is NCT04420702 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04420702?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04420702?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

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