To hear about similar clinical trials, please enter your email below
Trial Title:
Improving Hepatocellular Carcinoma Screening
NCT ID:
NCT05828446
Condition:
Magnetic Resonance Imaging
Hepatocellular Carcinoma
Screening
Contrast-enhanced US
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
single center interventional prospective study
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
MRI
Description:
To compare the diagnostic performance of US+/- Constrast-enhanced US and AMRI for HCC
detection in an at-risk population
Arm group label:
HCC screening population according to European Association for the Study of the Liver recommendation
Other name:
Constrast-enhanced US
Summary:
This is a monocentric, single blind, interventional, single arm study. It is designed to
compare the rates of detection of hepatocellular carcinoma (HCC) by ultrasound (US) used
in clinical routine vs. abbreviated magnetic resonance imaging (AMRI). The hypothesis is
that dynamic AMRI with extracellular contrast agent injection has a higher patient-level
detection rate of HCC than screening US and non-contrast AMRI.
Interested and eligible patients will be enrolled and undergo HCC screening rounds
including US +/- contrast-enhanced US (clinical routine) and screening MRI within the
same week bi-annually.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- All adult patients with chronic liver disease and indication for HCC screening
according to the European Association for the Study of the Liver recommendations.
- Informed Consent signed by the subject
Exclusion Criteria:
- History of HCC
- History of other malignancy
- Prior liver nodule categorized as LI-RAD 4, 5 or M
- History of liver transplantation
- Pregnancy
- MRI or MRI contrast agent precaution
- Any other condition making the patient unsuitable for the study
- Patient's refusal of transmission of relevant medical conditions found on the
medical examinations performed during the study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Lausanne University Hospital
Address:
City:
Lausanne
Zip:
1011
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Naik Vietti Violi, MD
Phone:
+41795560240
Email:
naik.vietti-violi@chuv.ch
Investigator:
Last name:
Naik Vietti Violi, MD
Email:
Principal Investigator
Investigator:
Last name:
Clarisse Dromain, MD
Email:
Sub-Investigator
Start date:
April 1, 2023
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Naik Vietti Violi
Agency class:
Other
Source:
University of Lausanne Hospitals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05828446
