- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03289884
MR Assessment of Hepatic Hydatid Disease
Multi-metric Quantitative MRI for the Assessment of Hepatic Hydatid Disease- a Pilot Study
Study Overview
Status
Conditions
Detailed Description
Cystic echincoccosis (CE), caused by infection with the dog tapeworm, is a major worldwide healthcare problem with increasing prevalence in the developed world. Approximately 75% of CE involves the liver, with treatments incurring significant cost and patient morbidity.
The key to CE treatment is correct identification of active infection but differentiation from sterile disease is highly problematic. Current treatment guidelines base activity assessment on morphological assessment with ultrasound (US), serology and light-microscopy of samples obtained at aspiration/surgery when available. Serology however can take many years to become negative even following successful treatment and US evaluation is subjective. Assessment of disease 'activity' is therefore a major challenge, particularly once patients are undergoing treatment. The lack of accurate tools to assess treatment response has undermined the development of management guidelines, particularly concerning the optimum length of chemotherapy treatment and indications for surgical/image-guided intervention.
Quantitative MR methods present a potential solution to this challenge. Magnetic Resonance Spectroscopy (MRS) has shown promising ex vivo results in detecting the biochemical "signature" of active infection in cyst fluid, but has yet to be applied clinically. Alternative approaches including T1 mapping, susceptibility mapping and Diffusion Weighted Imaging/Intra-voxel Incoherent Motion are also potentially useful, but have little supportive data to date.
Non-invasive biomarkers of CE activity are therefore essential to defining specific treatment endpoints, particularly in the context of chemotherapy. Multiple quantitative MR methods could be used to develop composite biomarkers for disease activity. Identifying a new quantitative radiological 'fingerprint' for each stage of the natural life-cycle of hepatic CE will enable improved diagnosis and therapeutic triage.
To date, in vivo liver quantitative MRI has not yet been applied to this cohort of patients, thus representing a novel application of this technology to address an important clinical question.
With this pilot study, the investigators aim to demonstrate the potential of quantitative MRI methods in the assessment of active/inactive hepatic CE.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Manil Chouhan, MBBS BSc
- Phone Number: 07779783511
- Email: m.chouhan@ucl.ac.uk
Study Contact Backup
- Name: Katerina Soteriou, BSc
- Email: katerina.soteriou@uclh.nhs.uk
Study Locations
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London, United Kingdom, NW1 2PG
- Recruiting
- University College London Hospital
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Contact:
- Manil Chouhan, MBBS BSc
- Phone Number: 07779783511
- Email: m.chouhan@ucl.ac.uk
-
Contact:
- Katerina Soteriou, BSc
- Email: katerina.soteriou@nhs.net
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Control Group (CE1)
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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
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CE group (CE2-4)
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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
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary outcome measure is MR spectroscopy metabolite
Time Frame: 1 year
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This will be assessed on water ratio
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1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: Bull World Health Organ. 2010 Mar;88(3):236.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16/0811
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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