Completed

Stratification of Patients With Chronic Liver Disease Using Multi Spectral CT

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What is being collected

Device Data

Collected from past medical records and data - Retrospective
Device
Who is being recruted

Adenocarcinoma+12

+ Carcinoma

+ Digestive System Diseases

Over 18 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 2013
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: April 17, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2013

Actual date on which the first participant was enrolled.

This is a retrospective study, in which a FDA approved imaging device (spectral CT scanner) currently used for several clinical applications will be evaluated for feasibility of studying chronic liver disease (this application has not yet been validated). Tomographic imaging has assumed a fundamental role in patients with Chronic Liver Disease (CLD) to screen patients for hepatocellular carcinoma (HCC), and, is increasingly being explored as a noninvasive alternative for characterizing liver fibrosis. The overarching goal of this study is to improve noninvasive characterization of liver fibrosis through spectral CT. Hypothesis: concentration of iodine-based contrast agent in the liver parenchyma during the delayed phase, as measured with spectral CT imaging, increases monotonically with Ishak fibrosis score obtained from liver biopsy. This hypothesis is supported by the literature and our preliminary data, described in the references section (Lamb et al. 2015). We will evaluate multiphase spectral CT images consisting of the arterial phase, 2-minute delayed phase, and 5-minute delayed phase. Fibrosis will be assessed on both delayed phase images, where it is assumed that any remaining contrast agent, in the liver, is due to the presence of fibrosis. This type of multiphase protocol can still be used to image CLD patients with spectral CT for HCC detection and, thus, will not interfere with liver lesion workup and evaluation.

Principal SponsorMassachusetts General Hospital
Last updated: April 17, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaCarcinomaDigestive System DiseasesDigestive System NeoplasmsFibrosisLiver NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinoma, HepatocellularLiver CirrhosisLiver Diseases

Criteria

2 inclusion criteria required to participate
Adult patient with chronic liver disease undergoing CT scan for/suspicion of hepatocellular carcinoma

Patients should be scheduled for/or should have obtained a multiphasic MRI of the liver

4 exclusion criteria prevent from participating
History of allergy to intravenous contrast

Patients < 18 years old

Patients at risk for contrast-induced-nephropathy

Pregnant patients

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Massachusetts General Hospital,

Boston, United StatesOpen Massachusetts General Hospital, in Google Maps
CompletedOne Study Center