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临床试验/NCT04539717
NCT04539717Enrolling By Invitation不适用

Abbreviated MRI for HCC Screening in Cirrhotic Patients (FAST-MRI Study)

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 820 人开始时间: 2020年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
820
试验地点
2
主要终点
Presence of HCC

研究概览

简要总结

The purpose of this study is to compare the diagnostic value of a reconstructed abbreviated Magnetic Resonance Imaging (MRI) from a full clinical exam, compared to ultrasound (US) for screening of liver cancer. Blood markers will be evaluated to determine their correlation to imaging. This study will help to determine whether abbreviated MRI is superior to ultrasound for diagnosis of liver cancer.

详细描述

Hepatocellular carcinoma (HCC) is the fastest growing cause of cancer death in the United States and now kills over 30,000 Americans annually. To reduce the morbidity and mortality caused by this aggressive cancer, current practice guidelines recommend semi-annual abdominal ultrasound in adults with cirrhosis, the leading risk factor for HCC, to detect HCC nodules when they are small and treatable. Unfortunately, US has poor sensitivity for early-stage HCC in cirrhosis, failing to detect treatable cancer in over half of affected patients. Alternatives such as computed tomography (CT) or magnetic resonance imaging (MRI) are also not ideal due to ionizing radiation (CT), higher cost (MRI), or long exam time (~30-45 min for MRI). An optimal and fast HCC screening method is urgently needed and should be more sensitive and cost-effective than US and avoid ionizing radiation.

This is a prospective cross-sectional single arm non randomized multicenter study enrolling in 4 American centers as follows: Icahn School of Medicine at Mount Sinai-ISMMS, University of California San Diego-UCSD, University of Wisconsin-UW, and Duke University. The composite reference standard will incorporate the clinical results of the full baseline MRI exam and of subsequent imaging and pathology data collected over the next 6 months. Routine clinical follow-up imaging at 6 months will be observed. Patients will then be classified as positive for HCC, negative for HCC, or excluded.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Presence of HCC

时间窗: Within 6 months after initial index imaging (MRI & US)

The presence of HCC will be determined by a composite reference standard. This composite reference standard incorporates the results of the complete MRI exam, pathology, and clinical follow-up.

次要结局

  • Serum AFP(Within 1 year of blood processing)
  • Circulating tumor DNA (ctDNA)(Within 1 year of blood processing)
  • Cost-effectiveness(Within 1 year after initial index imaging (MRI & US).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bachir Taouli

Professor, Radiology and Medicine

Icahn School of Medicine at Mount Sinai

研究点 (2)

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