FAST (Focused Abbreviated Screening Technique)-MRI Study
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|ClinicalTrials.gov Identifier: NCT04539717|
Recruitment Status : Enrolling by invitation
First Posted : September 7, 2020
Last Update Posted : October 18, 2022
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|Condition or disease|
|Hepatocellular Carcinoma (HCC) Liver Cirrhosis|
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.
|Study Type :||Observational|
|Estimated Enrollment :||820 participants|
|Official Title:||Evaluation of Liver Cancer With Magnetic Resonance Imaging (MRI)|
|Actual Study Start Date :||September 8, 2020|
|Estimated Primary Completion Date :||December 2025|
|Estimated Study Completion Date :||December 2025|
- 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.
- Circulating tumor DNA (ctDNA) [ Time Frame: Within 1 year of blood processing ]
- Serum AFP [ Time Frame: Within 1 year of blood processing ]Serum Alpha-Fetoprotein
- 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
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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|
- 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.
- 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.
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
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Bachir Taouli||Icahn School of Medicine at Mount Sinai|
|Responsible Party:||Bachir Taouli, Professor, Radiology and Medicine, Icahn School of Medicine at Mount Sinai|
|Other Study ID Numbers:||
1R01CA249765-01 ( U.S. NIH Grant/Contract )
|First Posted:||September 7, 2020 Key Record Dates|
|Last Update Posted:||October 18, 2022|
|Last Verified:||October 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Magnetic Resonance Imaging (MRI)
Digestive System Diseases