Clinical trial · Interventional
Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions
Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI
NCT02156739CI-TRIAL-00115575active not recruitingN/AClinicalTrials.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)
This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.
Conditions
Conditions (4)
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 |
| Liver and Intrahepatic Bile Duct Disorder | — | UNRESOLVED | — |
| Metastatic Malignant Neoplasm in the Liver | — | UNRESOLVED | — |
| Primary Malignant Liver Neoplasm | Primary Malignant Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-enhanced Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Gadobutrol | Drug | — | UNRESOLVED |
| Gadoxetate Disodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (contrast-enhanced MRI)
- description
- Patient receives each of these over one minute. For the gadoxetate disodium, dynamic imaging is performed immediately and imaging is performed at 20 minutes. For the gadobutrol, dynamic imaging is performed immediately.
- interventionNames
- Procedure: Contrast-enhanced Magnetic Resonance Imaging
- Drug: Gadobutrol
- Drug: Gadoxetate Disodium
Primary outcomes (1)
- measure
- Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI)
- timeFrame
- Up to 4 years
- description
- Summary statistics of sensitivity, specificity, true positives, true negatives, false positives, and false negatives will be provided for gadoxetate disodium and gadoxetate disodium + gadobutrol method. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value will be estimated along with corresponding 95% confidence intervals for the two methods. Comparison between the two methods will be made following method by Obuchowski. Other statistical analyses will be carried out as appropriate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week * Patients with renal function (estimated glomerular filtration rate \[eGFR\] \>= 30) * Any disease type Exclusion Criteria: * Pregnant women * Patients with impaired renal function (eGFR \< 30) * Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet * Patients with contraindications to the use of intravenous contrast such as allergic type reactions
References
Publications (0)
Data not yet available
No reference posted for this study.