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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03809559
Other study ID # MRCP_RR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 19, 2018
Est. completion date March 8, 2019

Study information

Verified date November 2018
Source Perspectum Diagnostics Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to determine the repeatability and reproducibility of Quantitative Magnetic Resonance Cholangiopancreatography (MRCP).

Imaging scientists at Perspectum Diagnostics have developed a hessian-based mathematical model to enhance conventional MRCP to a 3D geometric model of the biliary tree, 'Quantitative MRCP'. This enables advanced quantitative measurement of bile duct width, orientation, branching point and curvative metrics.

The technology has been validated against 3D printed phantoms for accuracy, and early clinical research has demonstrated the technology has potential for clinical impact, with improvement in radiologist performance versus conventional non-enhanced MRCP imaging (Vikal et al 2017).

Quantitative MRCP aims to act as a tool to not only improve assessment of the current status of the biliary tree, but also act as a mechanism to track change within the ducts. Thus, it must be established that any change between scans is due to change in the physiology of the individual and not due to a quirk or fault of the technology.

In order to achieve this a series of scans will be performed on an individual over a short period of time, for which the condition of the biliary tree within that individual can be assumed to be constant. Between each scan, subject and coil repositioning will occur.

The study will recruit a group of adult volunteers, from both diseased groups and healthy groups in order to achieve a range of physiological biliary metrics.


Description:

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Study Design


Intervention

Device:
MRCP+
Participants will undergo an initial abdominal MRI scan in a fasted state. They will then be asked to drink 400ml pineapple juice before undergoing four further abdominal MRI scans with short breaks in between each scan.

Locations

Country Name City State
United Kingdom Addenbrookes Hospital Cambridge Cambridgeshire
United Kingdom Oxford Centre for Clinical Magnetic Resonance Research Oxford Oxfordshire

Sponsors (1)

Lead Sponsor Collaborator
Perspectum Diagnostics Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Assessment of the impact of pineapple juice consumption upon LiverMultiScan performance Statistical assessment of the agreement among cT1, PDFF and T2* measurements before and after consuming pineapple juice. 6 months
Primary Assessment of Repeatability and Reproducibility of Quantitative MRCP Assessment of the variability of bile duct volume, bile duct diameter, branching points and locations of regions of variation in bile duct widths and percentages, as measured by quantitative MRCP between:
A. Repeated scans of the same participant acquired under the same conditions
B. Repeated scans of the same participant acquired on scanners which differ by field strength and/or manufacturer
6 months
Secondary Intra and Inter-operator reproducibility Statistical assessment of the agreement among quantitative MRCP analyses performed by both trained operators and expert radiologists. 6 months
Secondary Comparison of conventional MRCP and quantitative MRCP Statistical assessment of the agreement between quantitative MRCP analyses (performed by both trained operators and expert radiologists) and clinician ground truth (biliary tree assessment obtained by expert radiologists using conventional MRCP) 6 months
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