Prostate Diffusion Imaging With Distortion Correction

NCT06185478 — Not applicable, Withdrawn, Norfolk and Norwich University Hospitals NHS Foundation Trust

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Registry	NCT06185478
Status	Withdrawn - Study abandoned due to COVID-19 (07/06/2024).
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Sponsor	Norfolk and Norwich University Hospitals NHS Foundation Trust (Other); collaborators: University of East Anglia
Conditions	Prostate Cancer
Interventions	MRI scan (Diagnostic test)
Dates	start 2024-03-01 (estimated), primary completion 2027-01-01 (estimated), completion 2027-01-01 (estimated), first posted 2023-12-29, last updated 2026-06-08
Locations	1 site in United Kingdom

-Summary

There has been literature demonstrating the effectiveness of correcting these MRI images by using an additional measurement of the magnetic field, but the implied improvement in lesion detection in these common distorted regions in the prostate has yet to be shown.

We propose that introducing this distortion correction would greatly improve the DWI images used for tumour detection. For this study we propose testing this hypothesis as a primary objective, and as a secondary objective including additional b-values to further refine the ADC value. The study involves adding one additional distortion correcting scan to the standard clinical study, adding approximately 2 minutes to the study.

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+Arms and interventions

Arm	Type	Interventions	Description
Imaging	Experimental	Diagnostic Test: MRI scan

MRI scan (Diagnostic test): MRI scan

+Outcome measures

Primary outcomes

MRI image quality [12 months]: To determine whether correcting for the distortion in MRI images caused by rectal gas improves the image quality and thus diagnostic ability in localising and detecting prostate cancer

+Eligibility

Sex: Male, ages: 18 Years to 100 Years

Inclusion Criteria:

* Male
* Aged 18 and over
* No contraindication to MR scanning
* Smokers and non-smokers
* Patients who have had a complete scan on the 3T scan MRI at Norfolk and Norwich University Hospital and have gone on to have a biopsy at the Norfolk and Norwich University Hospital

Exclusion Criteria:

* Previous diagnosis of prostate cancer, prostatic biopsy or treatment for prostate cancer

+Locations (1)

Facility	City	Country	Status
Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich, Norfolk	United Kingdom

+Investigators

Paul Malcolm, Principal investigator, Norfolk and Norwich University Hospitals NHS Foundation Trust