MR Assessment of Hepatic Hydatid Disease

NCT03289884 | Unknown

• 1 other identifier: 16/0811
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Echincoccosis; Hydatid Disease

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is MR spectroscopy metabolite

  This will be assessed on water ratio

  1 year

Study Arms (2)

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); 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.

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

Interventions

MRI scan (not involving ionising radiation) OTHER

The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher

CE group (CE2-4); Control Group (CE1)

Ultrasound scan (not involving ionising radiation) OTHER

The US scan will be conducted by a nominated researcher

CE group (CE2-4); Control Group (CE1)

Ex vivo MRI scan of cyst fluid sample OTHER

The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher

CE group (CE2-4)

Aspiration of cyst fluid OTHER

For patients undergoing surgery/radiologically guided aspiration the aspiration will be performed by a surgeon (at the Royal Free Hospital) or radiologist

CE group (CE2-4)

Blood test for confirmation of serum IgG levels consistent with hydatid infection OTHER

The blood sample will be drawn by a member of the clinical team

CE group (CE2-4)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy
• Any contraindication to MRI (pacemakers, metallic implants, claustrophobia ect.)
• Inability to give consent

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, NW1 2PG, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 21814584 BACKGROUND

• 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.

  PMID: 16494758 BACKGROUND

• 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.

  PMID: 24532894 BACKGROUND

• 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.

  PMID: 20428353 BACKGROUND

MeSH Terms

Conditions

Echinococcosis

Interventions

Magnetic Resonance Spectroscopy; High-Energy Shock Waves; Hematologic Tests

Condition Hierarchy (Ancestors)

Cestode Infections; Helminthiasis; Parasitic Diseases; Infections

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Manil Chouhan, MBBS BSc

CONTACT

07779783511; m.chouhan@ucl.ac.uk

Katerina Soteriou, BSc

CONTACT

katerina.soteriou@uclh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: September 21, 2017
• Study Start: August 14, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

GB (1)