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.
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
- Conditions the study is for
- Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis, Gallstones
- 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
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 group | Role | What they receive |
|---|---|---|
| Biliary Conditions | Participants who have a history of a biliary tree related condition Receives: Device: MRCP+ | |
| Liver conditions | Participants who have a history of a non-biliary tree related liver condition Receives: Device: MRCP+ | |
| Healthy Volunteers | Participants 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.
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:
- Repeated scans of the same participant acquired under the same conditions
- Repeated scans of the same participant acquired on scanners which differ by field strength and/or manufacturer
Measured: 6 months
Secondary outcomes (2)
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
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.
- First posted18 Jan 2019
- Study start19 Jul 2018
- Primary completion8 Sep 2018
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajarshi Banerjee, BM BCh MSc DPhil, Principal investigator, Perspectum Diagnostics
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeatability and Reproducibility of Quantitative MRCP
- ClinicalTrials.gov ID
- NCT03809559
- Acronym / sponsor ID
- MRCP_RR
- Keywords
- Magnetic Resonance Cholangiopancreatography (MRCP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 8 Sep 2018 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biliary Conditions | – | Device: MRCP+Participants who have a history of a biliary tree related condition |
| Liver conditions | – | Device: MRCP+Participants who have a history of a non-biliary tree related liver condition |
| Healthy Volunteers | – | Device: MRCP+Participants who have do not have a diagnosed liver condition and are in general good health |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRCP+Also: Quantitative Magnetic Resonance Cholangiopancreatography, LiverMultiScan, Multiparametric MRI, MRI-PDFFParticipants 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. | Device | Biliary Conditions, Healthy Volunteers, Liver conditions |
Primary outcome
Assessment of Repeatability and Reproducibility of Quantitative MRCP
Time frame: 6 months
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
2 secondary outcomes
Intra and Inter-operator reproducibility
Time frame: 6 months
Comparison of conventional MRCP and quantitative MRCP
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajarshi Banerjee, BM BCh MSc DPhil principal investigator
Perspectum Diagnostics
2 sites in 1 country: see every site and its status.
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.