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FAST (Focused Abbreviated Screening Technique)-MRI Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04539717
Recruitment Status : Enrolling by invitation
First Posted : September 7, 2020
Last Update Posted : October 1, 2020
Sponsor:
Collaborators:
University of California, San Diego
Duke University
University of Wisconsin, Madison
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bachir Taouli, Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease
Hepatocellular Carcinoma (HCC) Liver Cirrhosis

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 820 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Liver Cancer With Magnetic Resonance Imaging (MRI)
Actual Study Start Date : August 17, 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025





Primary Outcome Measures :
  1. Presence of HCC [ Time Frame: 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.


Secondary Outcome Measures :
  1. Circulating tumor DNA (ctDNA) [ Time Frame: Within 1 year of blood processing ]
  2. Serum AFP [ Time Frame: Within 1 year of blood processing ]
    Serum Alpha-Fetoprotein

  3. Cost-effectiveness [ Time Frame: Within 1 year after initial index imaging (MRI & US). ]
    The cost-effectiveness will be assessed using a micro simulation model.


Biospecimen Retention:   Samples With DNA
Blood will be collected to measure AFP, AFP-L3 and DCP (Des-carboxy-prothrombin), ctDNA and other tumor markers. The research team will not perform whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen) as part of this study.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosed liver cirrhosis enrolled in imaging-based screening for HCC.
Criteria

Inclusion Criteria

  • Liver cirrhosis of any etiology.
  • 18 years of age and older.
  • Enrolled in screening/surveillance program for HCC.
  • Clinically indicated imaging-based screening for HCC.
  • Willing and able to complete all study procedures within specified time windows.
  • Patient is able to give informed consent for this study.

Exclusion Criteria

  • Contra-indications to MRI.
  • Age less than 18 years.
  • Patients with chronic renal failure or inability to tolerate contrast.
  • Inability to undergo MRI due to lack of insurance coverage.
  • Prior negative screening exam less than 5 months prior to enrollment.
  • Prior hepatic resection.
  • Post liver transplantation.
  • Previously treated HCC or other liver neoplasm.
  • Any other condition or factor that in judgment of study investigator may interfere with study completion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04539717


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
University of California, San Diego
Duke University
University of Wisconsin, Madison
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Bachir Taouli Icahn School of Medicine at Mount Sinai
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Responsible Party: Bachir Taouli, Professor, Radiology and Medicine, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04539717    
Other Study ID Numbers: GCO 19-1409
1R01CA249765-01 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bachir Taouli, Icahn School of Medicine at Mount Sinai:
Magnetic Resonance Imaging (MRI)
Ultrasound (US)
Liver Diseases
Elastography
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Liver Cirrhosis
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases