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NCT02578602 · ClinicalTrials.gov registry record · Phase 1
MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer
A Phase 1 study of Advanced Adult Hepatocellular Carcinoma and Adult Hepatocellular Carcinoma, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT02578602: Completed Phase 1 study of Advanced Adult Hepatocellular Carcinoma and Adult Hepatocellular Carcinoma, sponsored by University of Southern California.
NCT02578602 is a Phase 1 study of Advanced Adult Hepatocellular Carcinoma and Adult Hepatocellular Carcinoma that has completed, run by University of Southern California. The registered enrollment target is 26 participants, roughly in line with the 28-participant average among 3 other Advanced Adult Hepatocellular Carcinoma trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02578602, a Phase 1 study of Advanced Adult Hepatocellular Carcinoma and Adult Hepatocellular Carcinoma, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
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).
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Magnetic Resonance Imaging
- DRUG Gadoxetate Disodium
Study Locations (1)
California
- USC / Norris Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-10 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT02578602 record still lists
NCT02578602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, roughly in line with the 28-participant average among 3 other Advanced Adult Hepatocellular Carcinoma trials with a reported enrollment target.
The record links to 9 conditions, with Advanced Adult Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT02578602 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02578602 about?
NCT02578602 is a clinical study titled "MRI With Gadoxetate Disodium in Measuring Tumors in Patients With Liver Cancer". 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 y...
What is the current status of trial NCT02578602?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2010-10. Estimated completion is 2015-06.
What conditions does trial NCT02578602 study?
This clinical trial studies the following conditions: Advanced Adult Hepatocellular Carcinoma, Adult Hepatocellular Carcinoma, BCLC Stage B Adult Hepatocellular Carcinoma, BCLC Stage C Adult Hepatocellular Carcinoma, BCLC Stage 0 Adult Hepatocellular Carcinoma.
What interventions are being tested in trial NCT02578602?
The interventions under investigation include: Magnetic Resonance Imaging (DEVICE), Gadoxetate Disodium (DRUG).
Who is sponsoring clinical trial NCT02578602?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02578602 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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