Hydatid Disease Clinical Trial
Official title:
Multi-metric Quantitative MRI for the Assessment of Hepatic Hydatid Disease- a Pilot Study
NCT number | NCT03289884 |
Other study ID # | 16/0811 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 14, 2017 |
Est. completion date | March 1, 2020 |
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | March 1, 2020 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria for Control group: - All patients must have cystic lesions which must exceed 30 mm in diameter. - All patients must be fasted and avoid caffeinated fluids for at least 4 hours prior to the scan. - All patients must be aged 16 or over and able to provide informed consent. Inclusion Criteria for the CE group: - All patients must have hepatic CE, as confirmed by positive serology, with lesions identified on teh standard of care MRI/CT scan, one or more of which must exceed 20 mm in diameter. - All patients must be fasted and avoid caffeinated fluids for at least 4 hours prior to the scan. - All patients must be aged 16 or over and able to provide informed consent. Exclusion Criteria: - Pregnancy - Any contraindication to MRI (pacemakers, metallic implants, claustrophobia ect.) - Inability to give consent |
Country | Name | City | State |
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United Kingdom | University College London Hospital | London |
Lead Sponsor | Collaborator |
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University College, London |
United Kingdom,
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. — View Citation
Benner C, Carabin H, Sánchez-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. Erratum in: Bull World Health Organ. 2010 Mar;88(3):236. — View Citation
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. — View Citation
Budke CM, Deplazes P, Torgerson PR. Global socioeconomic impact of cystic echinococcosis. Emerg Infect Dis. 2006 Feb;12(2):296-303. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome measure is MR spectroscopy metabolite | This will be assessed on water ratio | 1 year |
Status | Clinical Trial | Phase | |
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Completed |
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