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Multi-metric Quantitative MRI for the Assessment of Hepatic Hydatid Disease- a Pilot Study
Sponsor study identifier
observational
24
1 country
1
Study Start
August 14, 2017
Actual (reported)Primary Completion
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Hydatid disease is a major healthcare problem worldwide caused by infection that commonly affects the liver. Treatments for hydatid disease depend on how advanced the disease is and if the infection is active or not. Currently, doctors decide what stage the disease is at by looking at the appearance of liver on scans and by performing blood tests. It is however still very difficult to be certain if a treatment is working and when is the right moment to start and stop medication. Magnetic Resonance Imaging (MRI) scanning is a safe and non-invasive way of imaging the liver that can provide detailed information not just about what the liver looks like but also other information about the chemical composition of normal and diseased liver tissue. MRI is already widely used in the NHS for many liver conditions but it is unknown whether analysing the chemical composition will help decide on the stage and activity of hydatid liver disease. This study will allow comparison between MRI information about liver structure and composition with existing methods of assessing disease stage. If fluid is later obtained from the liver as part of usual clinical care (either using a needle with ultrasound or at the time of surgery), this study will also compare information about the fluid composition obtained from MRI scanning, with the results obtained when analysing the fluid in the lab. This will help to develop a more accurate way of non-invasively assessing hydatid disease in the liver, in the future.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 7, 2017
Actual (reported)August 14, 2017
Actual (reported)September 21, 2017
Actual (reported)March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The primary outcome measure is MR spectroscopy metabolite
This will be assessed on water ratio
1 year
* All patients must have cystic lesions which must exceed 30mm in diameter. * All patients must be aged 16 or over and able to provide informed consent. * Patients will have an MRI scan (not involving ionising radiation) * Patients wil have an 'Ultrasound scan (not involving ionising radiation)' * Exclusion criteria include pregnancy and any contraindication to MRI (pacemaker, metallic implants, claustrophobia) and inability to give consent.
* All patients must have hepatic CE, as confirmed by positive blood tests, with lesions identified on the standard of care MRI/CT scan, one or more of which must exceed 20 mm in diameter. * All patients must be aged 16 or over and able to provide informed consent. * All patients will have an MRI scan (not involving ionising radiation) * Patients wil have an 'Ultrasound scan (not involving ionising radiation)' * Exclusion criteria include pregnancy and any contraindication to MRI (pacemaker, metallic implants, claustrophobia) and inability to give consent. * Patients from the CE group undergoing surgery or aspiration will have fluid samples sent for analysis as part of standard clinical care. These cyst fluid samples will then be transported to the MRI scanner for Ex vivo scanning.
The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
The US scan will be conducted by a nominated researcher
Recruitment will take place at the hydatid liver disease multidisciplinary team meetings where patients are discussed and considered for inclusion. These patients can be recruited via outpatient consultation clinics.
University College London Hospital
London, NW1 2PG, United Kingdom
Brunetti E, Garcia HH, Junghanss T; International CE Workshop in Lima, Peru, 2009. Cystic echinococcosis: chronic, complex, and still neglected. PLoS Negl Trop Dis. 2011 Jul;5(7):e1146. doi: 10.1371/journal.pntd.0001146. Epub 2011 Jul 26. No abstract available.
Budke CM, Deplazes P, Torgerson PR. Global socioeconomic impact of cystic echinococcosis. Emerg Infect Dis. 2006 Feb;12(2):296-303. doi: 10.3201/eid1202.050499.
First Submitted
August 7, 2017
First Posted
September 21, 2017
Study Start
August 14, 2017
Actual (reported)Primary Completion
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
For patients undergoing surgery/radiologically guided aspiration the aspiration will be performed by a surgeon (at the Royal Free Hospital) or radiologist
The blood sample will be drawn by a member of the clinical team
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Anand S, Rajagopalan S, Mohan R. Management of liver hydatid cysts - Current perspectives. Med J Armed Forces India. 2012 Jul;68(3):304-9. doi: 10.1016/j.mjafi.2012.04.010.
Benner C, Carabin H, Sanchez-Serrano LP, Budke CM, Carmena D. Analysis of the economic impact of cystic echinococcosis in Spain. Bull World Health Organ. 2010 Jan;88(1):49-57. doi: 10.2471/BLT.09.066795.
Study Completion
March 1, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 4, 2018
Record last verified: 2018-05
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