Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies (Hepatica)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03213314
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : October 4, 2019
Sponsor:
Collaborators:
Hampshire Hospitals NHS Foundation Trust
Perspectum Diagnostics Ltd
Information provided by (Responsible Party):
University of Edinburgh

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Cancer Surgery Liver Regeneration Colorectal Cancer Metastatic Diagnostic Test: Multiparameter magnetic resonance imaging Not Applicable

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Nested cohort study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
Actual Study Start Date : September 7, 2017
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Arm Intervention/treatment
Experimental: Main cohort
Patients undergoing liver resection
Diagnostic Test: Multiparameter magnetic resonance imaging
LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.
Other Name: LiverMultiScan

Experimental: Nested cohort PVE
Patients undergoing liver resection after portal vein embolisation
Diagnostic Test: Multiparameter magnetic resonance imaging
LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.
Other Name: LiverMultiScan

Experimental: Nested cohort neoadjuvant chemotherapy
Patients undergoing liver resection after neoadjuvant chemotherapy
Diagnostic Test: Multiparameter magnetic resonance imaging
LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.
Other Name: LiverMultiScan

Experimental: Nested cohort TACE
Patients undergoing trans arterial chemoembolisation for presumed hepatocellular carcinoma
Diagnostic Test: Multiparameter magnetic resonance imaging
LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.
Other Name: LiverMultiScan




Primary Outcome Measures :
  1. Correlation between the pre-operative liver health assessment score and the post-operative liver function composite integer-based risk score. [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures :
  1. To compare LiverMultiScan image interpretations with histological findings [ Time Frame: 24 months ]
    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

  2. • To evaluate LiverMultiScan image interpretations correlated with post-operative length of stay. [ Time Frame: 24 months ]
    • 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03213314


Locations
Layout table for location information
United Kingdom
Hampshire Hospitals Foundation Trust
Basingstoke, United Kingdom
NHS Lothian Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
Sponsors and Collaborators
University of Edinburgh
Hampshire Hospitals NHS Foundation Trust
Perspectum Diagnostics Ltd
Investigators
Layout table for investigator information
Principal Investigator: Damian J Mole, MBChB PhD University of Edinburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03213314     History of Changes
Other Study ID Numbers: AC17009
223180 ( Other Identifier: IRAS )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Controlled access of study data through a reasonable request to the study management team, after a reasonable embargo period after completion of the study

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Edinburgh:
LiverMultiScan
multiparameter MRI
functional liver remnant
liver resection
hepatic resection
portal vein embolisation
preoperative liver function
postoperative liver failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics