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Repeatability and Reproducibility of Quantitative MRCP

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ClinicalTrials.gov Identifier: NCT03809559
Recruitment Status : Completed
First Posted : January 18, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Perspectum Diagnostics Ltd

Tracking Information
First Submitted Date January 15, 2019
First Posted Date January 18, 2019
Last Update Posted Date August 27, 2019
Actual Study Start Date July 19, 2018
Actual Primary Completion Date September 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2019)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03809559 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 17, 2019)
  • Intra and Inter-operator reproducibility [ Time Frame: 6 months ]
    Statistical assessment of the agreement among quantitative MRCP analyses performed by both trained operators and expert radiologists.
  • Comparison of conventional MRCP and quantitative MRCP [ Time Frame: 6 months ]
    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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 17, 2019)
Assessment of the impact of pineapple juice consumption upon LiverMultiScan performance [ Time Frame: 6 months ]
Statistical assessment of the agreement among cT1, PDFF and T2* measurements before and after consuming pineapple juice.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Repeatability and Reproducibility of Quantitative MRCP
Official Title Repeatability and Reproducibility of Quantitative MRCP
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Primary Sclerosing Cholangitis
  • Primary Biliary Cirrhosis
  • Gallstones
  • Liver Diseases
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.
Other Names:
  • Quantitative Magnetic Resonance Cholangiopancreatography
  • LiverMultiScan
  • Multiparametric MRI
  • MRI-PDFF
  • MRCP
Study Groups/Cohorts
  • Biliary Conditions
    Participants who have a history of a biliary tree related condition
    Intervention: Device: MRCP+
  • Liver conditions
    Participants who have a history of a non-biliary tree related liver condition
    Intervention: Device: MRCP+
  • Healthy Volunteers
    Participants who have do not have a diagnosed liver condition and are in general good health
    Intervention: Device: MRCP+
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 17, 2019)
40
Original Estimated Enrollment Same as current
Actual Study Completion Date March 8, 2019
Actual Primary Completion Date September 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03809559
Other Study ID Numbers MRCP_RR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Perspectum Diagnostics Ltd
Study Sponsor Perspectum Diagnostics Ltd
Collaborators Not Provided
Investigators
Principal Investigator: Rajarshi Banerjee, BM BCh MSc DPhil Perspectum Diagnostics
PRS Account Perspectum Diagnostics Ltd
Verification Date November 2018