An observational study in Cystic Echincoccosis and Hydatid Disease, sponsored by University College, London. Status unknown at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-05-04.
Sponsored by University College, London · Observational
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.
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.
25 studies on the registry are indexed under Echinococcosis; 4 are open to participants now.
This study's planned enrollment of 24 is below the median of 45 across 18 observational studies indexed under Echinococcosis.
Browse Echinococcosis studies →University College, London is the lead sponsor of 651 studies on the registry; 149 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria for Control group:
Inclusion Criteria for the CE group:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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) · Other: Ultrasound scan (not involving ionising radiation)
* 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) · 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
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
The primary outcome measure is MR spectroscopy metabolite
This will be assessed on water ratio
Time frame: 1 year
Started Aug 2017 (actual). Primary completion is estimated for Mar 2020, 30 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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