Prostate Diffusion Imaging With Distortion Correction

Prostate Cancer Clinical Trial

Official title:

Prostate Diffusion Imaging With Distortion Correction

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT06185478
• Other study ID #: 250301 (15-02-19)
• Status: Suspended
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: January 1, 2027

Study information

• Verified date: December 2023
• Source: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 70
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• MRI scan
MRI scan

Locations

Country	Name	City	State
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich	Norfolk

Sponsors (2)

Lead Sponsor	Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust	University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI image quality	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	12 months