Clinical trial · Observational
Utility of Abbreviated Magnetic Resonance Imaging as a Screening Tool for Hepatocellular Carcinoma in Cirrhotic Patients
NCT05716620CI-TRIAL-00063787unknownClinicalTrials.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 goal of this study is Utility of abbrevational magnetic resonance imaging as a screening tool for hepatocellular carcinoma in cirrhotic patients. The primary objective of the study is: • HCC detection rate of US vs AMRI in cirrhotic patients The secondary objective of the study are: * False referral rate of US vs AMRI: false referral will be defined as lack of HCC on complete MRI despite a positive US or AMRI. * Positive predictive value of US vs AMRI: The positive predictive value will be defined as the number of patients with true positive results in patients with positive US/AMRI. Participants will be evaluated by two rounds of screening 6 months apart using paired US and non-enhanced AMRI.
Conditions
Conditions (1)
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 | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- HCC detection rate of US vs AMRI in cirrhotic patients
- timeFrame
- Day 7 from the time of enrolment till 12 month's scan
- description
- number of HCCs detected by US / AMRI divided by the actual number of HCCs based reference standard
Secondary outcomes (5)
- measure
- False referral rate
- timeFrame
- Day 7 from the time of enrolment till 12 month's scan
- description
- number of false positive results divided by the sum of true negative and false- positive results
- measure
- Sensitivity, specificity of US vs AMRI
- timeFrame
- Day 7 from the time of enrolment till 12 month's scan
- description
- Sensitivity, specificity of US vs AMRI
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age\>40 years 2. Presence of cirrhosis 3. Annual risk of HCC \>5% 4. No HCC on pre-enrollment imaging not more than 6 months back. 5. Risk factors including diabetes mellitus, metabolic syndrome, family history of HCC. Exclusion Criteria: 1. Child C status 2. Diagnosed or follow up case of HCC 3. Other malignancies 4. Pregnancy, lactation 5. Contraindications to MRI (pacemaker, cochlear implant, claustrophobia) 6. Chronic renal disease or contrast allergy precluding administration of intravenous MRI contrast agent (for reference standard)
References
Publications (10)
- BACKGROUNDCenter MM, Jemal A. International trends in liver cancer incidence rates. Cancer Epidemiol Biomarkers Prev. 2011 Nov;20(11):2362-8. doi: 10.1158/1055-9965.EPI-11-0643. Epub 2011 Sep 15. PMID 21921256
- BACKGROUNDKalra N, Gupta P, Chawla Y, Khandelwal N. Locoregional treatment for hepatocellular carcinoma: The best is yet to come. World J Radiol. 2015 Oct 28;7(10):306-18. doi: 10.4329/wjr.v7.i10.306. PMID 26516427
- BACKGROUNDRoayaie S, Obeidat K, Sposito C, Mariani L, Bhoori S, Pellegrinelli A, Labow D, Llovet JM, Schwartz M, Mazzaferro V. Resection of hepatocellular cancer </=2 cm: results from two Western centers. Hepatology. 2013 Apr;57(4):1426-35. doi: 10.1002/hep.25832. Epub 2013 Jan 25. PMID 22576353
- BACKGROUNDKanwal F, Singal AG. Surveillance for Hepatocellular Carcinoma: Current Best Practice and Future Direction. Gastroenterology. 2019 Jul;157(1):54-64. doi: 10.1053/j.gastro.2019.02.049. Epub 2019 Apr 12. PMID 30986389
- BACKGROUNDSingal A, Volk ML, Waljee A, Salgia R, Higgins P, Rogers MA, Marrero JA. Meta-analysis: surveillance with ultrasound for early-stage hepatocellular carcinoma in patients with cirrhosis. Aliment Pharmacol Ther. 2009 Jul;30(1):37-47. doi: 10.1111/j.1365-2036.2009.04014.x. Epub 2009 Apr 8. PMID 19392863
- BACKGROUNDTzartzeva K, Obi J, Rich NE, Parikh ND, Marrero JA, Yopp A, Waljee AK, Singal AG. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018 May;154(6):1706-1718.e1. doi: 10.1053/j.gastro.2018.01.064. Epub 2018 Feb 6. PMID 29425931
- BACKGROUNDKim YK, Kim YK, Park HJ, Park MJ, Lee WJ, Choi D. Noncontrast MRI with diffusion-weighted imaging as the sole imaging modality for detecting liver malignancy in patients with high risk for hepatocellular carcinoma. Magn Reson Imaging. 2014 Jul;32(6):610-8. doi: 10.1016/j.mri.2013.12.021. Epub 2014 Jan 13.