Clinical trial · Observational
FAST (Focused Abbreviated Screening Technique)-MRI Study
Abbreviated MRI for HCC Screening in Cirrhotic Patients (FAST-MRI Study)
NCT04539717CI-TRIAL-00096422enrolling by invitationClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Presence of HCC
- timeFrame
- Within 6 months after initial index imaging (MRI & US)
- description
- 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 outcomes (3)
- measure
- Circulating tumor DNA (ctDNA)
- timeFrame
- Within 1 year of blood processing
- measure
- Serum AFP
- timeFrame
- Within 1 year of blood processing
- description
- Serum Alpha-Fetoprotein
- measure
- Cost-effectiveness
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLewis S, Wildman-Tobriner B, Cuevas J, Calle S, Bolger I, Wang K, Joshi H, Mankowski Gettle L, Yang JD, Min JH, Sirlin CB, Reeder SB, Bashir MR, Taouli B. Quality of Gadoxetate-enhanced MRI versus US during Hepatocellular Carcinoma Screening in Participants with Cirrhosis. Radiology. 2026 Feb;318(2):e251497. doi: 10.1148/radiol.251497. PMID 41665498