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

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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

Information provided by (Responsible Party):

University of Edinburgh

Study Description

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.

Study Design

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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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 :

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
• 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

Eligibility Criteria

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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

Contacts and Locations

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

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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

Investigators

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Principal Investigator:	Damian J Mole, MBChB PhD	University of Edinburgh

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mole DJ, Fallowfield JA, Sherif AE, Kendall T, Semple S, Kelly M, Ridgway G, Connell JJ, McGonigle J, Banerjee R, Brady JM, Zheng X, Hughes M, Neyton L, McClintock J, Tucker G, Nailon H, Patel D, Wackett A, Steven M, Welsh F, Rees M; HepaT1ca Study Group. Quantitative magnetic resonance imaging predicts individual future liver performance after liver resection for cancer. PLoS One. 2020 Dec 2;15(12):e0238568. doi: 10.1371/journal.pone.0238568. eCollection 2020.

Mole DJ, Fallowfield JA, Kendall TJ, Welsh F, Semple SI, Bachtiar V, Kelly M, Wigmore SJ, James Garden O, Wilman HR, Banerjee R, Rees M, Brady M. Study protocol: HepaT1ca - an observational clinical cohort study to quantify liver health in surgical candidates for liver malignancies. BMC Cancer. 2018 Sep 12;18(1):890. doi: 10.1186/s12885-018-4737-3.

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Responsible Party:	University of Edinburgh
ClinicalTrials.gov Identifier:	NCT03213314
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

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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:

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Liver Neoplasms Digestive System Neoplasms Neoplasms by Site	Neoplasms Digestive System Diseases Liver Diseases

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