Improving Hepatocellular Carcinoma Screening

Официальное название

Prospective Comparison of Diagnostic Performance and Cost-effectiveness of US and Abbreviated MRI for Hepatocellular Carcinoma Screening

Обзор

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.

Вмешательства

• Устройство MRI
  To compare the diagnostic performance of US+/- Constrast-enhanced US and AMRI for HCC detection in an at-risk population

Первичные конечные точки

• To compare the diagnostic performance of US+/- CEUS and AMRI for HCC detection in an at-risk population [Срок оценки: Through study completion, an average of 1 year.]

Вторичные конечные точки (5)

• Compare the patient-level accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of US +/- CEUS vs. AMRI for HCC. [Срок оценки: Through study completion, an average of 1 year.]
• Evaluate patient satisfaction and comfort with US +/- CEUS vs. AMRI with a questionnaire [Срок оценки: Once, after the first screening round (US+/-CEUS and MRI), 6 months]
• To develop and test a DL model for HCC detection based on AMRI. [Срок оценки: Through study completion, an average of 1 year.]
• To perform a cost-effectiveness analysis comparing US to different alternative screening strategies for HCC in Switzerland. [Срок оценки: Through study completion, an average of 1 year.]
• To perform a cost-effectiveness analysis comparing US to different alternative screening strategies for HCC in Switzerland. [Срок оценки: Through study completion, an average of 1 year.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Швейцария · 1 центр

• Lausanne University Hospital — Lausanne

Идентификаторы

NCT: NCT05828446 · CER-VD 2022-D0116

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗