MR Assessment of Hepatic Hydatid Disease

Hydatid Disease Clinical Trial

Official title:

Multi-metric Quantitative MRI for the Assessment of Hepatic Hydatid Disease- a Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03289884
• Other study ID #: 16/0811
• Status: Recruiting
• Start date: August 14, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: May 2018
• Source: University College, London
• Contact: Manil Chouhan, MBBS BSc
• Phone: 07779783511
• Email: m.chouhan[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Echincoccosis
• Hydatid Disease

Intervention

Other:
• MRI scan (not involving ionising radiation)
The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
• Ultrasound scan (not involving ionising radiation)
The US scan will be conducted by a nominated researcher
• Ex vivo MRI scan of cyst fluid sample
The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
• 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
• 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

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View Citation

Benner C, Carabin H, Sánchez-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. — View Citation

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. — View Citation

Budke CM, Deplazes P, Torgerson PR. Global socioeconomic impact of cystic echinococcosis. Emerg Infect Dis. 2006 Feb;12(2):296-303. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is MR spectroscopy metabolite	This will be assessed on water ratio	1 year