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Prostate Imaging Using MRI +/- Contrast Enhancement

NCT04571840 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-09-23

No results posted yet for this study

Summary

This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer.

This means that we are comparing MRI scans that requires injection of IV contrast (the current standard practice) versus MRI scans that can be performed without IV contrast in the detection of prostate cancer.

Conditions

Interventions

DIAGNOSTIC_TEST

Multiparametric MRI +/- prostate biopsy

MRI with T2-weighted, diffusion weighted and dynamic contrast enhanced sequences followed by prostate biopsy if indicated on MRI and clinical findings

DIAGNOSTIC_TEST

Biparametric MRI +/- prostate biopsy

MRI with T2-weighted and diffusion weighted sequences followed by prostate biopsy if indicated on MRI and clinical findings

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Veeru Kasivisvanathan, MBBS PhD · University College, London

  • Caroline Moore, MD FRCS · University College, London

  • Mark Emberton, MD FRCS · University College, London

  • Clare Allen, FRCR · University College London Hospital

  • Shonit Punwani, PhD FRCR · University College, London

  • Francesco Giganti, MD · University College, London

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-22
Primary Completion
2024-12-01
Completion
2025-03-01
FDA Device
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Netherlands
  • Singapore
  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04571840 on ClinicalTrials.gov