HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies

NCT ID: NCT03213314

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-07
• Study Completion Date: 2019-03-31

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.

Conditions

Liver Cancer; Surgery; Liver Regeneration; Colorectal Cancer Metastatic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Main cohort

Patients undergoing liver resection

Group Type: EXPERIMENTAL

Multiparameter magnetic resonance imaging

Intervention Type: DIAGNOSTIC_TEST

LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.

Nested cohort PVE

Patients undergoing liver resection after portal vein embolisation

Group Type: EXPERIMENTAL

Multiparameter magnetic resonance imaging

Intervention Type: DIAGNOSTIC_TEST

LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.

Nested cohort neoadjuvant chemotherapy

Patients undergoing liver resection after neoadjuvant chemotherapy

Group Type: EXPERIMENTAL

Multiparameter magnetic resonance imaging

Intervention Type: DIAGNOSTIC_TEST

LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.

Nested cohort TACE

Patients undergoing trans arterial chemoembolisation for presumed hepatocellular carcinoma

Group Type: EXPERIMENTAL

Multiparameter magnetic resonance imaging

Intervention Type: DIAGNOSTIC_TEST

LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.

Interventions

Multiparameter magnetic resonance imaging

LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

LiverMultiScan

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hampshire Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Perspectum

INDUSTRY

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damian J Mole, MBChB PhD

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

Hampshire Hospitals Foundation Trust

Basingstoke, , United Kingdom

NHS Lothian Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33264327 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30208871 (View on PubMed)

Other Identifiers

223180

Identifier Type: OTHER

Identifier Source: secondary_id

AC17009

Identifier Type: -

Identifier Source: org_study_id