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

Not yet recruiting

• Conditions: Prostate Cancer; MRI

• Registration Number: NCT06672926
• Lead Sponsor: University Hospitals of North Midlands NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-11-01
• Study First Posted: 2024-11-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Study Start: 2025-05
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Use of Gadolinium Based Contrast Agent (GBCA) injection	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	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	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

Trial Locations

Locations (1)

University Hospitals of North Midlands NHS Trust; 🇬🇧 Stoke-on-Trent, Staffordshire, United Kingdom