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NCT03023566 · ClinicalTrials.gov registry record
Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI
A clinical trial, sponsored by Phoenix Children's Hospital.
- Completed
- Registry status
- 250
- Enrollment target
NCT03023566: Completed study, sponsored by Phoenix Children's Hospital.
NCT03023566 is a clinical trial that has completed, run by Phoenix Children's Hospital. The registered enrollment target is 250 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03023566 has completed, sponsored by Phoenix Children's Hospital.
- COMPLETED
- Registry status
- 250 participants
- Enrollment target
Study Summary
The goal of this study is to evaluate safety and efficacy of Dotarem enhanced MRI in pediatric and neonatal population who are referred for contrast enhanced MRI at Phoenix Children's Hospital.
Primary Outcome
Overall lesion visualization and characterization, based on assessment of (1) lesion border delineation, (2) internal morphology and (3) degree of contrast enhancement. All images from "Pre" (unenhanced MRI) and "Paired" (unenhanced + enhanced) MRI will be evaluated independently by the 3 independent readers and are rated on a 3-point scale as unevaluable (0), seen but imperfectly (1) or seen completely/perfectly (2). The primary statistical analysis compared unenhanced MRI to combined MRI. The
Interventions
- DRUG Dotarem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2017-02-09 |
| Est. Completion | 2017-11-12 |
What the finished NCT03023566 record still lists
NCT03023566 is an observational study that tracks outcomes without assigning an intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Dotarem is the first listed.
NCT03023566 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03023566 about?
NCT03023566 is a clinical study titled "Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI". The goal of this study is to evaluate safety and efficacy of Dotarem enhanced MRI in pediatric and neonatal population who are referred for contrast enhanced MRI at Phoenix Children's Hospital.
What is the current status of trial NCT03023566?
This trial is currently completed. The enrollment target is 250 participants. The study started on 2017-02-09. Estimated completion is 2017-11-12.
What interventions are being tested in trial NCT03023566?
The interventions under investigation include: Dotarem (DRUG).
Who is sponsoring clinical trial NCT03023566?
This trial is sponsored by Phoenix Children's Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
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