Repeatability and Reproducibility of Quantitative MRCP

NCT03809559 | Completed

• 1 other identifier: MRCP_RR
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Primary Sclerosing Cholangitis; Primary Biliary Cirrhosis; Gallstones; Liver Diseases

Keywords

Magnetic Resonance Cholangiopancreatography (MRCP)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Intra and Inter-operator reproducibility

  6 months

• Comparison of conventional MRCP and quantitative MRCP

  6 months

Other Outcomes (1)

• Assessment of the impact of pineapple juice consumption upon LiverMultiScan performance

  6 months

Study Arms (3)

Biliary Conditions

Participants who have a history of a biliary tree related condition

Device: MRCP+

Liver conditions

Participants who have a history of a non-biliary tree related liver condition

Device: MRCP+

Healthy Volunteers

Participants who have do not have a diagnosed liver condition and are in general good health

Device: MRCP+

Interventions

MRCP+ DEVICE

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.

Also known as: Quantitative Magnetic Resonance Cholangiopancreatography, LiverMultiScan, Multiparametric MRI, MRI-PDFF, MRCP

Biliary Conditions; Healthy Volunteers; Liver conditions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified in one of two ways. * Participants who have previously taken part in one of Perspectum's ethically approved studies and consented during that study to be contacted again in the event of any future study. * Participants who self-identify via advertisement on Perspectum's online and social media channels, or through collaboration with the investigator's charity partners.

You may qualify if:

• Persons over the age of 18 years
• Participant is willing and able to give informed consent for participation in the study.
• EITHER: Participant has a medical history of a liver or biliary tree related condition OR: Person is a healthy volunteer.

You may not qualify if:

• The participant may not enter the study if they have any contraindication to magnetic resonance imaging (inc pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
• The participant may not enter the study if they have an allergy to pineapple juice.
• Any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study

Sponsors & Collaborators

• Perspectum: lead

Study Sites (2)

Addenbrookes Hospital

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Oxford Centre for Clinical Magnetic Resonance Research

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Cholangitis, Sclerosing; Liver Cirrhosis, Biliary; Gallstones; Liver Diseases

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholestasis, Intrahepatic; Cholestasis; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cholelithiasis; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Rajarshi Banerjee, BM BCh MSc DPhil

  Perspectum Diagnostics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 18, 2019
• Study Start: July 19, 2018
• Primary Completion: September 8, 2018
• Study Completion: March 8, 2019
• Last Updated: August 28, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)