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Primary Sclerosing CholangitisNCT03809559

Repeatability and Reproducibility of Quantitative MRCP

An observational study of Primary Sclerosing Cholangitis and Primary Biliary Cirrhosis, run by Perspectum at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
MRCP+
Type of treatment
Medical device
How many people
40 participants
Where
2 sitesUnited Kingdom
Study dates
19 Jul 2018to 8 Mar 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • Addenbrookes Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • Oxford Centre for Clinical Magnetic Resonance Research

    Oxford, Oxfordshire, OX3 9DU

Other trials in United Kingdom

About this study

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.

Read more

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.

Read the detailed description

Biliary-related conditions, such as autoimmune conditions Primary Biliary Cholangitis (PBC), and Primary Sclerosing Cholangitis (PSC), and also cancers such as cholangiocarcinoma, affect tens of thousands of individuals in the UK each year. All biliary conditions require careful tracking of the structure and integrity of the biliary tree so that intervention can be carefully planned and with that, outcomes improved.

The current non-invasive gold-standard for assessment of the biliary tree is MRI-based Magnetic Resonance Cholangiopancreatography (MRCP). This method uses no contrast and takes up to 10 minutes to obtain within a normal scan event. However, there are several limitations to its use which include, images having great variability in quality and are used mainly for qualitative analysis. Using conventional MRCP a consultant can, depending on image quality; identify key structures, inform diagnosis, and give a general assessment on the health of the biliary tree structure. However, current MRCP imaging only allows limited quantitative assessment of the ducts. More extensive, objective quantification has the potential to dramatically improve the usability of MRCP imaging.With this in mind, 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 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). Thus, further research into the technology and its viability as an enhancement to current procedure is necessary if it is to replace conventional MRCP as the primary method of non-invasive biliary assessment.

Integral to the development of any new technology, is demonstration of the repeatability and reproducibility of the method. This is the inter-examination variability in results. 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.

The above will be tested by a series of scans 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.

Quantitative MRCP is an MRI based method, requiring no contrast, however consuming a drink containing manganese improves the quality of MRCP images significantly (Frisch et al., 2017), and therefore patients are routinely asked to drink pineapple juice (naturally high in manganese) before having a clinical MRCP scan. At present, multiparametric MRI to assess the health of liver tissue is performed in a fasted state (Banerjee et al., 2014), however, in order to offer a comprehensive liver scan including both MRCP and multiparametric MRI in the same scan, it is important to understand whether consuming pineapple juice will affect the multiparametric MRI measurements of cT1, PDFF and T2*.

MRI is safe and non-invasive, with no known risks to patients as long as they are appropriately screened to ensure they have no contraindications to MRI (e.g.pacemaker, metal implant that is not certified as MR-safe).

Being tested
MRCP+
Keywords
Magnetic Resonance Cholangiopancreatography (MRCP)
Medical subject headings
Cholangitis, Sclerosing, Liver Cirrhosis, Biliary, Gallstones, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRCP+Device

    Also called Quantitative Magnetic Resonance Cholangiopancreatography, LiverMultiScan, Multiparametric MRI, MRI-PDFF

    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.

Study groups in NCT03809559
Study groupRoleWhat they receive
Biliary ConditionsParticipants who have a history of a biliary tree related condition
Receives: Device: MRCP+
Liver conditionsParticipants who have a history of a non-biliary tree related liver condition
Receives: Device: MRCP+
Healthy VolunteersParticipants who have do not have a diagnosed liver condition and are in general good health
Receives: Device: MRCP+

What is being measured

The primary outcome is the main question the study is designed to answer.

  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:

    1. Repeated scans of the same participant acquired under the same conditions
    2. Repeated scans of the same participant acquired on scanners which differ by field strength and/or manufacturer

    Measured: 6 months

Secondary outcomes (2)
  1. Intra and Inter-operator reproducibility

    Statistical assessment of the agreement among quantitative MRCP analyses performed by both trained operators and expert radiologists.

    Measured: 6 months

  2. 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)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2019
  2. Study start19 Jul 2018
  3. Primary completion8 Sep 2018
  4. Study completion8 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03809559
Sponsor's protocol ID
MRCP_RR
Status last verified
Nov 2018
First submitted
15 Jan 2019
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Primary Sclerosing Cholangitis and Primary Biliary Cirrhosis, run by Perspectum at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of Repeatability and Reproducibility of Quantitative MRCP (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.

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