Clinical trial · Interventional
MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer
MR Techniques in the Evaluation of Hepatocellular Carcinoma: Gadoxetate
NCT02578602CI-TRIAL-00019512completedPhase 1ClinicalTrials.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 pilot clinical trial studies magnetic resonance imaging (MRI) with gadoxetate disodium in measuring tumors in patients with liver cancer. Diagnostic procedures, such as MRI with gadoxetate disodium, may help find and diagnose liver cancer and find out how far the disease has spread. It is not yet known whether MRI with gadoxetate disodium provides a more precise measurement of liver tumors than standard computed tomography (CT).
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Advanced Adult Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
| BCLC Stage 0 Adult Hepatocellular Carcinoma | — | UNRESOLVED | — |
| BCLC Stage A Adult Hepatocellular Carcinoma | BCLC Stage A Adult Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| BCLC Stage B Adult Hepatocellular Carcinoma | BCLC Stage B Adult Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| BCLC Stage C Adult Hepatocellular Carcinoma | BCLC Stage C Adult Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| BCLC Stage D Adult Hepatocellular Carcinoma | BCLC Stage D Adult Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Localized Non-Resectable Adult Liver Carcinoma |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gadoxetate Disodium | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (gadoxetate disodium MRI)
- description
- Patients receive gadoxetate disodium IV and then undergo enhanced liver MRI.
- interventionNames
- Drug: Gadoxetate Disodium
- Device: Magnetic Resonance Imaging
Primary outcomes (1)
- measure
- Precision in tumor measurement for each type of image (CT vs. MRI), for each phase ( 4 for CT and 5 for MRI), and for each method of measuring "size" (1-,2-, and 3-dimensional), assessed by low inter- and intra-reader variability
- timeFrame
- Up to 24 hours
- description
- Initially, a random effects analysis of variance (ANOVA) will be performed for each type of image (CT vs. MRI), for each phase (4 for CT and 5 for MRI) and for each method of measuring "size" (1-, 2-, and 3-dimensional) - for a total of 27 ANOVAs. Lesion, radiologist, and replication (for the 20 target lesions measured twice) will all be random effects; the inter-reader and the intra-reader variability will be estimated from these models and 95% confidence intervals will be constructed.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* CT features suggestive of HCC, including those features which have been described herein; they are also enumerated below:
* For an arterially-enhancing lesion greater than or equal to 1 cm, but under 2 cm, all of the following criteria must be met:
* Imaging features of a mass
* Wash-out on later phases of contrast administration
* At least 1 cm or more growth
* For an arterially-enhancing lesion greater than or equal to 2 cm, two of the following criteria must be met:
* Imaging features of a mass
* Wash-out on later phases of contrast administration
* At least 1 cm or more growth
* All enhancing lesions with expansile, solid, enhancing tumor within vascular structures will be included, including the main portal vein, the main right and main left portal veins, the inferior vena cava (IVC), and the main hepatic veins
* No prior history of treatment of liver lesions
* Able to provide written and verbal informed consent
* Able to tolerate a complete abdominal MR examination, within 3 weeks of CT
Exclusion Criteria:
* Unable to provide written and verbal informed consent
* Unable to undergo MRI due to intraocular metallic foreign body, pacemaker, or other contraindications including objects in the body which are deemed to be unsafe or notable to be assessed, or unable to undergo MRI within 3 weeks of CT
* Pregnancy
* Severe renal insufficiency as defined by an estimated glomerular filtration rate of less than 30 cc/minute
* Severe liver disease as defined by Childs class C cirrhosis
* History of a previous reaction to contrast media
* History of bronchial asthma
* History of allergic disorders
* Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation periodReferences
Publications (0)
Data not yet available
No reference posted for this study.