Clinical trial NCT03213314: HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
Official title: HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Surgery
Liver Regeneration
Colorectal Cancer Metastatic
Keywords: LiverMultiScan
multiparameter MRI
functional liver remnant
liver resection
hepatic resection
portal vein embolisation
preoperative liver function
postoperative liver failure
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Hampshire Hospitals NHS Foundation Trust
name: Perspectum
First posted: 2017-07-11
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nested cohort study
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Correlation between the pre-operative liver health assessment score and the post-operative liver function composite integer-based risk score.
timeFrame: 24 months
Secondary outcomes:
measure: To compare LiverMultiScan image interpretations with histological findings
timeFrame: 24 months
measure: • To evaluate LiverMultiScan image interpretations correlated with post-operative length of stay.
timeFrame: 24 months
Other outcomes:
Locations:
city: Basingstoke
country: United Kingdom
facility: Hampshire Hospitals Foundation Trust
city: Edinburgh
country: United Kingdom
facility: NHS Lothian Royal Infirmary of Edinburgh
Study officials:
affiliation: University of Edinburgh
name: Damian J Mole, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.