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Clinical Trials/NCT06672926
NCT06672926
Recruiting
Not Applicable

NEWPROMRI-PATHWAY - A New Prostate Magnetic Resonance Imaging (MRI) Pathway

University Hospitals of North Midlands NHS Trust1 site in 1 country1,600 target enrollmentSeptember 23, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
University Hospitals of North Midlands NHS Trust
Enrollment
1600
Locations
1
Primary Endpoint
Use of Gadolinium Based Contrast Agent (GBCA) injection
Status
Recruiting
Last Updated
last month

Overview

Brief Summary

Prostate cancer is the second most common cancer in men worldwide. The demand for magnetic resonance imaging (MRI) to diagnose and manage prostate cancer is continually growing. There is, however, a severe global shortage of radiologists who review and make decisions on prostate scans. This shortage causes compromises that are inefficient and negatively affect care provision, patient outcomes, and patient experiences. Two key examples of these compromises are that every patient receives a gadolinium contrast injection during a prostate MRI scan and patients often require multiple imaging appointments. If radiologists' knowledge of making prostate MRI decisions around these compromises could be harnessed and passed to radiographers (who are trained to acquire the MRIs but currently do not review them) with a computerised system to support clinical decision-making, this would have enormous potential to improve the diagnosing and managing prostate cancer.

Registry
clinicaltrials.gov
Start Date
September 23, 2025
End Date
December 1, 2026
Last Updated
last month
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • MRI radiographers in University Hospitals of North Midlands (UHNM) and or University Hospitals of Derby and Burton (UHDB) with over 5 years' experience in MRI of the prostate.
  • Radiographers from UHNM or UHDB who have completed an online and hands on study specific training materials before the testing phase.
  • Retrospective data of 800 patients each from UHNM and UHDB who have had mpMRI and went on to have a biopsy.

Exclusion Criteria

  • Non-MRI radiographers.
  • Radiographers who did not completed an online and hands on study specific training materials before the testing phase.
  • Non-mpMRI.

Outcomes

Primary Outcomes

Use of Gadolinium Based Contrast Agent (GBCA) injection

Time Frame: 12 months

Equivalence between radiographers and radiologists in deciding when Gadolinium Based Contrast Agent (GBCA) injection is required in prostate MRI scans. This is by comparing radiographers' diagnoses (decisions on whether GBCA injection would have been required) with radiologists' decisions to determine equivalence in prostate cancer diagnosis using prostate MRI.

Application of WB-MRI

Time Frame: 12 months

Equivalence between radiographers and radiologists in deciding when WB-MRI is required in prostate MRI scans. This is by comparing radiographers' decisions (decisions on whether WB-MRI would have been required) with radiologists' decisions to determine equivalence in prostate cancer diagnosis using prostate MRI.

Radiographers opinions

Time Frame: 12 months

The Decisional Conflict Scale (DCS) will be used to capture radiographers' opinions on how they felt about the tasks and support they are given during their preparation and afterward

Study Sites (1)

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