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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 is a Phase 4 study that has completed, run by Bracco Diagnostics. The registered enrollment target is 229 participants.
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.
Interventions
- DRUG gadoteridol
- DRUG gadobutrol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01613417
The ClinicalTrials.gov registry entry for NCT01613417 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bracco Diagnostics, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which gadoteridol is the first listed.
NCT01613417 reports 0 study locations.
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.
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