Comparison Of DIR-MRI And DCE-MRI In Detection Of Prostate Cancer: A Pilot Study

Cancer of the Prostate Clinical Trial

— DIRMP  

Official title:

Comparison Of Double Inversion Recovery Magnetic Resonance Imaging (Dir-Mri) And Dynamic Contrast Enhanced Magnetic Imaging (Dce-Mri) In Detection Of Prostate Cancer: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939456
• Other study ID #: 1139
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: April 30, 2017

Study information

• Verified date: May 2018
• Source: University Hospitals of North Midlands NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI).

Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team.

Description:

This is a pilot study taking place at University Hospitals of North Midlands NHS Trust. Patients referred for MRI for possible prostate cancer will be invited to take part in the study. Following consent, participants will have an additional MRI sequence performed during their routine MRI called Double Inversion Magnetic Resonance Imaging (DIR-MRI). Participants scan images and prostate biopsy histology report (if applicable) will be reviewed by the research team. The research team will look at the variability of LNR score amongst the two scan typed and the DCE-MRI and DIR-MRI images will be correlated with biopsy results to give an indication of the accuracy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 30, 2017
• Est. primary completion date: April 12, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients referred for prostate MRI for possible prostate cancer

• Safe to undergo an MRI scan

• Able to give informed consent

Exclusion Criteria:

• MRI referrals where prostate cancer is not the question

• Patients who are not safe to undergo an MRI scan

• Patients who have undergone prostate biopsy in the previous 10 weeks

• Patients unable to give informed consent

Related Conditions & MeSH terms

• Cancer of the Prostate
• Prostatic Neoplasms

Intervention

Other:
• Magnetic Resonance Imaging
Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) and Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)

Locations

Country	Name	City	State
United Kingdom	University Hospitals of North Midlands NHS Trust	Stoke-on-Trent	Staffordshire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals of North Midlands NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion to Normal tissue Ratio (LNR) recorded for DIR-MRI and DCE-MRI	In order to inform a sample size calculation for a subsequent, fully powered equivalence trial Is DIR-MRI equivalent to DCE-MRI in detection of prostate cancer	3 months
Secondary	Correlation of biopsy and DIR-MRI and DCE-MRI findings	In order to ascertain if addition of DIR-MRI could improve accuracy of cancer diagnosis	3 months