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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03213314
Other study ID # AC17009
Secondary ID 223180
Status Completed
Phase N/A
First received
Last updated
Start date September 7, 2017
Est. completion date March 31, 2019

Study information

Verified date October 2019
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This observational clinical cohort study aims to evaluate the clinical utility of LiverMultiScan in quantifying liver health prior to liver resection or TACE. The results will enable further developments in scanning protocols and software, and clearly define the relevance of applying this technology as part of the pre-operative assessment of the patient being considered for liver resection or TACE.


Description:

The liver is unique among the abdominal organs for the capacity to regenerate post-operatively. However, a minimum functional liver remnant (FLR) is required for patients to survive the initial perioperative period. At present, the assessment of the FLR is based on volume alone, in the context of clinical judgment and surrogate markers of liver function based on blood tests. Recently, Perspectum Diagnostics have developed and validated LiverMultiScan, an MRI-based technology that can non-invasively quantify fibroinflammatory disease in addition to steatosis and iron content. In this project, we plan to use LiverMultiScan as an additional direct measurement of liver health prior to resectional surgery or transarterial chemoembolization (TACE), so that liver volume and function can be combined. For example, surgery with a predicted FLR of 21% might be survivable if the liver tissue was in extremely good health, whereas surgery with a predicted FLR of 40% might be lethal if the liver tissue was in poor health. Occasionally, portal vein embolization (PVE) is performed to promote hypertrophy of the FLR. Furthermore, non-resectional intervention, for example TACE for primary liver cancers, is well-tolerated by patients with healthy livers, but can lead to serious liver decompensation and liver failure if TACE is delivered to a liver in poor health. Currently, the available imaging modalities are limited in their ability to assess liver health in liver resection or TACE candidates. Liver fat content (steatosis) can be assessed with CT, or more accurately with MRI. However, fibroinflammatory disease, which has been shown to correlate with post-resection morbidity, typically requires an invasive biopsy to diagnose accurately.

This research project will support the definition, development and technical validation of Hepatica, which aims to build on the MRI technology underlying LiverMultiScan and develop the additional functionality required to meet this clinical need.


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date March 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients being considered for liver resection

Exclusion Criteria:

- i. Patients under the age of 18 years will be excluded from the present study. ii. Prisoners will be excluded from the present study. iii. Persons unable to have an MRI scan (including but not limited to claustrophobia, implanted metallic devices, metal foreign body) iv. Adults with incapacity v. Non-provision of consent

Study Design


Intervention

Diagnostic Test:
Multiparameter magnetic resonance imaging
LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.

Locations

Country Name City State
United Kingdom Hampshire Hospitals Foundation Trust Basingstoke
United Kingdom NHS Lothian Royal Infirmary of Edinburgh Edinburgh

Sponsors (3)

Lead Sponsor Collaborator
University of Edinburgh Hampshire Hospitals NHS Foundation Trust, Perspectum Diagnostics Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between the pre-operative liver health assessment score and the post-operative liver function composite integer-based risk score. Correlation between the pre-operative liver health assessment score (Hepatica score - calculated by weighting future remnant liver volume by liver inflammation and fibrosis (LIF) score) and the post-operative liver function composite integer-based risk (Hyder-Pawlik) score. 24 months
Secondary To compare LiverMultiScan image interpretations with histological findings To compare LiverMultiScan image interpretations with clinical outcome after surgery in three domains: post-operative liver function, surgery-specific complication rate, and overall complication rate 24 months
Secondary • To evaluate LiverMultiScan image interpretations correlated with post-operative length of stay. • To compare LiverMultiScan image interpretations with histological findings in the resected liver specimen in four domains: fibrosis, inflammation, fat content and iron load as title 24 months
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