HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies

NCT03213314 | Completed DMC

• 2 other identifiers: AC17009223180
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To compare LiverMultiScan image interpretations with histological findings

  24 months

• • To evaluate LiverMultiScan image interpretations correlated with post-operative length of stay.

  24 months

Study Arms (4)

Main cohort

EXPERIMENTAL

Patients undergoing liver resection

Diagnostic Test: Multiparameter magnetic resonance imaging

Nested cohort PVE

EXPERIMENTAL

Patients undergoing liver resection after portal vein embolisation

Diagnostic Test: Multiparameter magnetic resonance imaging

Nested cohort neoadjuvant chemotherapy

EXPERIMENTAL

Patients undergoing liver resection after neoadjuvant chemotherapy

Diagnostic Test: Multiparameter magnetic resonance imaging

Nested cohort TACE

EXPERIMENTAL

Patients undergoing trans arterial chemoembolisation for presumed hepatocellular carcinoma

Diagnostic Test: Multiparameter magnetic resonance imaging

Interventions

Multiparameter magnetic resonance imaging DIAGNOSTIC_TEST

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

Also known as: LiverMultiScan

Main cohort; Nested cohort PVE; Nested cohort TACE; Nested cohort neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients being considered for liver resection

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Edinburgh: lead
• Hampshire Hospitals NHS Foundation Trust: collaborator
• Perspectum: collaborator

Study Sites (2)

Hampshire Hospitals Foundation Trust

Basingstoke, United Kingdom

Location

NHS Lothian Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33264327 DERIVED

• 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.

  PMID: 30208871 DERIVED

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Damian J Mole, MBChB PhD

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Nested cohort study

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 11, 2017
• Study Start: September 7, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

GB (2)