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Quantitative MRI and Outcomes of Liver Resection

NCT06181318 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2023-12-26

No results posted yet for this study

Summary

The present observational study aims to assess the benefit of this quantitative multiparametric magnetic resonance imaging (MRI) in clinical practice, to quantify future liver remnant performance, and to accurately predict the risk of liver failure after major hepatectomy, among patients undergoing major liver resection.

The main questions to be answered are:

* Can multiparametric MRI predict the postoperative liver function?
* Can multiparametric MRI predict the postoperative liver-specific complications as well as mortality? With ethical approval and fully informed consent, patients being considered for major liver resection will undergo clinical assessment, blood sampling, and multiparametric MRI before surgery. For the primary outcome, 33 participants will be needed to detect a minimum correlation coefficient of 0.2 with 5% significance and 80% power.

Conditions

Interventions

DIAGNOSTIC_TEST

Multiparametric MRI scan of the liver

MRI scans will be performed at the Champalimaud Foundation using a 1.5T scanner after patients have fasted for 4 hours. Transverse abdominal T1 maps will be acquired to estimate extracellular fluid (which increases in cases of fibrosis and inflammation) and T2\* maps will be acquired to estimate liver iron levels. These quantitative MRI maps will be laid onto the volumetric images of Couinaud segments. Multi-slice quantitative maps will be generated using Liver MultiScan software (Perspectum, UK) with operators blinded to patient status. T1 measurements will be adjusted for the iron level to give iron-corrected T1 maps (cT1). Reference ranges for cT1 have been defined in the general population. PDFF maps of the liver will be calculated using MRI multi-echo and spoiled-gradient-echo acquisition. No intravenous contrast agents will be used in Liver MultiScan maps and the total scan duration will be approximately 30 minutes.

Sponsors & Collaborators

  • Fundacao Champalimaud

    collaborator OTHER

  • University Hospital Heidelberg

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-12-31
Completion
2025-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06181318 on ClinicalTrials.gov