HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies

Surgery Clinical Trial

— Hepatica  

Official title:

HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03213314
• Other study ID #: AC17009
• Secondary ID: 223180
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Liver Cancer
• Liver Neoplasms
• Liver Regeneration
• Surgery

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