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MR Assessment of Hepatic Hydatid Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03289884
Recruitment Status : Unknown
Verified May 2018 by University College, London.
Recruitment status was:  Recruiting
First Posted : September 21, 2017
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:
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.

Condition or disease Intervention/treatment
Cystic Echincoccosis Hydatid Disease Other: MRI scan (not involving ionising radiation) Other: Ultrasound scan (not involving ionising radiation) Other: Ex vivo MRI scan of cyst fluid sample Other: Aspiration of cyst fluid Other: Blood test for confirmation of serum IgG levels consistent with hydatid infection

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.

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Multi-metric Quantitative MRI for the Assessment of Hepatic Hydatid Disease- a Pilot Study
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control Group (CE1)
  • 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.
Other: MRI scan (not involving ionising radiation)
The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher

Other: Ultrasound scan (not involving ionising radiation)
The US scan will be conducted by a nominated researcher

CE group (CE2-4)
  • 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.
Other: MRI scan (not involving ionising radiation)
The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher

Other: Ultrasound scan (not involving ionising radiation)
The US scan will be conducted by a nominated researcher

Other: Ex vivo MRI scan of cyst fluid sample
The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher

Other: Aspiration of cyst fluid
For patients undergoing surgery/radiologically guided aspiration the aspiration will be performed by a surgeon (at the Royal Free Hospital) or radiologist

Other: Blood test for confirmation of serum IgG levels consistent with hydatid infection
The blood sample will be drawn by a member of the clinical team




Primary Outcome Measures :
  1. The primary outcome measure is MR spectroscopy metabolite [ Time Frame: 1 year ]
    This will be assessed on water ratio



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03289884


Contacts
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Contact: Manil Chouhan, MBBS BSc 07779783511 m.chouhan@ucl.ac.uk
Contact: Katerina Soteriou, BSc katerina.soteriou@uclh.nhs.uk

Locations
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United Kingdom
University College London Hospital Recruiting
London, United Kingdom, NW1 2PG
Contact: Manil Chouhan, MBBS BSc    07779783511    m.chouhan@ucl.ac.uk   
Contact: Katerina Soteriou, BSc       katerina.soteriou@nhs.net   
Sponsors and Collaborators
University College, London
Publications:
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03289884    
Other Study ID Numbers: 16/0811
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Echinococcosis
Cestode Infections
Helminthiasis
Parasitic Diseases