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NCT01613417 · ClinicalTrials.gov registry record · Phase 4
Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain
A Phase 4 study, sponsored by Bracco Diagnostics.
- Completed
- Registry status
- Phase 4
- Development phase
- 229
- Enrollment target
NCT01613417: Completed Phase 4 study, sponsored by Bracco Diagnostics.
NCT01613417 is a Phase 4 study that has completed, run by Bracco Diagnostics. The registered enrollment target is 229 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01613417, a Phase 4 study, has completed, sponsored by Bracco Diagnostics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 229 participants
- Enrollment target
Study Summary
This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.
Primary Outcome
Assessed by 3 blinded readers for each of the 198 patients who had post-dose exams for both ProHance and Gadovist/Gadavist. Readers assessed whether images with ProHance were preferred or images with Gadovist/Gadavist were preferred, or whether images after both exams were considered equal.
Interventions
- DRUG gadoteridol
- DRUG gadobutrol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
What the finished NCT01613417 record still lists
NCT01613417 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 2 interventions - of which gadoteridol is the first listed.
NCT01613417 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01613417 about?
NCT01613417 is a clinical study titled "Comparison of Prohance® With Gadovist®/Gadavist™ in Magnetic Resonance Imaging (MRI) of the Brain". This study aims at a direct comparison between ProHance (0.1 mmol/kg) and a validated comparator Gadovist/Gadavist (0.1 mmol/kg) in a crossover intra-individual design in subjects with brain tumors to confirm the identical overall technical and diagnostic performance of the two MR contrast agents.
What is the current status of trial NCT01613417?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 229 participants. The study started on 2012-08. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01613417?
The interventions under investigation include: gadoteridol (DRUG), gadobutrol (DRUG).
Who is sponsoring clinical trial NCT01613417?
This trial is sponsored by Bracco Diagnostics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01613417's enrollment target sits among peer trials
229 374th of 2000 higher than 1,627 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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