Clinical trial · Observational
Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver
Gadoxetic Acid-enhanced MR Evaluation of Hepatocellular Carcinoma and Dysplastic Nodules in the Cirrhotic Liver: Prospective Pathologic Correlation With Explanted Liver
NCT01501240CI-TRIAL-00013584PriMPawithdrawnClinicalTrials.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)
A prospective intra-individual study to investigate the diagnostic performance of gadoxetic acid-enhanced MR for the patients with liver cirrhosis using thin-section whole-explant as standard of reference
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 |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- liver cirrhosis, liver transplantation
- description
- Patients with known liver cirrhosis and planned to undergo liver transplantation within 1 month will be eligible population in the study
Primary outcomes (1)
- measure
- Diagnostic sensitivity of gadoxetic acid-enhanced MR imaging to detect HCC in the cirrhotic liver, using thin-section whole-explant as the standard of reference
- timeFrame
- Within the first week after liver explantation
Secondary outcomes (3)
- measure
- Specificity of gadoxetic acid-enhanced MR imaging to detect HCC in the cirrhotic liver, using thin-section whole-explant as standard of reference
- timeFrame
- Within the first week after liver explantation
- measure
- Sensitivity and specificity of gadoxetic acid-enhanced MR imaging to detect dysplastic nodules
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with known liver cirrhosis based on either histology, or a combination of physical examination, laboratory tests, and imaging data * Patients with known liver cirrhosis based on either histology, or a combination of physical examination, laboratory tests, and imaging data Exclusion Criteria: * Patients under 20 years of age * Patients who have more than 10 nodules detected on hepatobiliary phase of gadoxetic acid-enhanced MR * Patients who underwent transarterial chemotherapy or radiofrequency ablation * Women who are pregnant, lactating or who are of childbearing potential * Patients with any physical or mental status than interferes with the signing of informed consent * Patients with a contraindication for MR * Patients with impaired renal function (e.g. acute renal failure or eGFR \< 30 ml/min/1.73m2) or patients on dialysis
References
Publications (3)
- BACKGROUNDKudo M. Will Gd-EOB-MRI change the diagnostic algorithm in hepatocellular carcinoma? Oncology. 2010 Jul;78 Suppl 1:87-93. doi: 10.1159/000315235. Epub 2010 Jul 8. PMID 20616589
- BACKGROUNDZech CJ, Reiser MF, Herrmann KA. Imaging of hepatocellular carcinoma by computed tomography and magnetic resonance imaging: state of the art. Dig Dis. 2009;27(2):114-24. doi: 10.1159/000218343. Epub 2009 Jun 22. PMID 19546549
- BACKGROUNDTanimoto A, Lee JM, Murakami T, Huppertz A, Kudo M, Grazioli L. Consensus report of the 2nd International Forum for Liver MRI. Eur Radiol. 2009 Oct;19 Suppl 5:S975-89. doi: 10.1007/s00330-009-1624-y. PMID 19851766