NEWPROMRI-PATHWAY - A New Prostate Magnetic Resonance Imaging (MRI) Pathway
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Hospitals of North Midlands NHS Trust
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Non-MRI radiographers.
Radiographers who did not completed an online and hands on study specific training materials before the testing phase.
Non-mpMRI.
Trial population
Uro-radiologists will be asked to take part, along with radiographers and members of a prostate cancer charity group
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Use of Gadolinium Based Contrast Agent (GBCA) injection
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.
Time frame
12 months2
Application of WB-MRI
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.
Time frame
12 months3
Radiographers opinions
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
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov