Cystic EchincoccosisNCT03289884
MR Assessment of Hepatic Hydatid Disease
An observational study of Cystic Echincoccosis and Hydatid Disease, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Echincoccosis, Hydatid Disease
- What is being tested?
- MRI scan (not involving ionising radiation), Ultrasound scan (not involving ionising radiation) and Ex vivo MRI scan of cyst fluid sample
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Aug 2017to 1 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- Pregnancy
- Any contraindication to MRI (pacemakers, metallic implants, claustrophobia ect.)
- Inability to give consent
Trial locations and contacts
1 site in 1 country.
Katerina Soteriou, BSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London, NW1 2PG
Manil Chouhan, MBBS BSc, 07779783511, m.chouhan@ucl.ac.uk
Katerina Soteriou, BSc, katerina.soteriou@nhs.net
About this study
Official title: Multi-metric Quantitative MRI for the Assessment of Hepatic Hydatid Disease- a Pilot Study
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.
Read the 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.
- Conditions
- Cystic Echincoccosis, Hydatid Disease
- Being tested
- MRI scan (not involving ionising radiation), Ultrasound scan (not involving ionising radiation), Ex vivo MRI scan of cyst fluid sample, Aspiration of cyst fluid, Blood test for confirmation of serum IgG levels consistent with hydatid infection
- Medical subject headings
- Echinococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI scan (not involving ionising radiation)Other
The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
Ultrasound scan (not involving ionising radiation)Other
The US scan will be conducted by a nominated researcher
Ex vivo MRI scan of cyst fluid sampleOther
The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
Aspiration of cyst fluidOther
For patients undergoing surgery/radiologically guided aspiration the aspiration will be performed by a surgeon (at the Royal Free Hospital) or radiologist
Blood test for confirmation of serum IgG levels consistent with hydatid infectionOther
The blood sample will be drawn by a member of the clinical team
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MRI scan (not involving ionising radiation); Other: Ultrasound scan (not involving ionising radiation) | |
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is MR spectroscopy metabolite
This will be assessed on water ratio
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start14 Aug 2017
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cystic EchincoccosisStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289884
- Sponsor's protocol ID
- 16/0811
- Status last verified
- May 2018
- First submitted
- 7 Aug 2017
- Last updated
- 4 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 21814584Budke 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.
PubMed 16494758Anand 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.
PubMed 24532894Benner 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.
PubMed 20428353
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-metric Quantitative MRI for the Assessment of Hepatic Hydatid Disease- a Pilot Study
- ClinicalTrials.gov ID
- NCT03289884
- Acronym / sponsor ID
- 16/0811
- Conditions
- Cystic Echincoccosis, Hydatid Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (CE1) | – | Other: MRI scan (not involving ionising radiation), Other: Ultrasound scan (not involving ionising radiation)* 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. |
| CE group (CE2-4) | – | 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* 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (3 listed)
- Pregnancy
- Any contraindication to MRI (pacemakers, metallic implants, claustrophobia ect.)
- Inability to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI scan (not involving ionising radiation)The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher | Other | CE group (CE2-4), Control Group (CE1) |
| Ultrasound scan (not involving ionising radiation)The US scan will be conducted by a nominated researcher | Other | CE group (CE2-4), Control Group (CE1) |
| Ex vivo MRI scan of cyst fluid sampleThe MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher | Other | CE group (CE2-4) |
| Aspiration of cyst fluidFor patients undergoing surgery/radiologically guided aspiration the aspiration will be performed by a surgeon (at the Royal Free Hospital) or radiologist | Other | CE group (CE2-4) |
| Blood test for confirmation of serum IgG levels consistent with hydatid infectionThe blood sample will be drawn by a member of the clinical team | Other | CE group (CE2-4) |
Primary outcome
The primary outcome measure is MR spectroscopy metabolite
Time frame: 1 year
This will be assessed on water ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Background: PubMed 21814584Brunetti 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.
- Background: PubMed 16494758Budke 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.
- Background: PubMed 24532894Anand 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.
- Background: PubMed 20428353Benner 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katerina Soteriou, BSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Echincoccosis and Hydatid Disease, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manil Chouhan, MBBS BSc (07779783511, m.chouhan@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is MR spectroscopy metabolite (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03289884, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.