Trials / Completed
CompletedNCT03750188
Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs
The Safety and Efficacy of ProHance® at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients Who Are Younger Than 2 Years of Age
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 125 (actual)
- Sponsor
- Bracco Diagnostics, Inc · Industry
- Sex
- All
- Age
- 1 Day – 2 Years
- Healthy volunteers
- Not accepted
Summary
Safety and Efficacy Study in pediatric subjects \<2 years of age who have undergone Brain or Spine MRI pre and post 0.1 mmol/kg ProHance administration. Imaging conditions will represent those in routine clinical practice. Retrospective enrolment with a prospective blinded read.
Detailed description
The purpose of this study is to retrospectively enroll children younger than 2 years of age who have undergone brain or spine MRI with 0.1 mmol/kg PROHANCE and to gather safety data as well as to collect MR images for a prospective blinded read to evaluate the efficacy of PROHANCE in terms of visualization and enhancing properties. The study will be conducted in 4-8 sites in the United States and Europe. It is estimated that 120 patients will be enrolled to provide 108 evaluable patients. Three radiologists unaffiliated with enrolling centers (blinded readers), blinded to the patient's identity and clinical profile will independently evaluate the MRI images. The efficacy analysis will be primarily based on the blinded reader evaluations. Imaging conditions will represent those in routine clinical practice, inclusive of pre and post-contrast images.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ProHance | 0.1 mmol/kg ProHance intravenous injection |
Timeline
- Start date
- 2018-11-01
- Primary completion
- 2019-09-17
- Completion
- 2019-10-16
- First posted
- 2018-11-21
- Last updated
- 2020-01-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03750188. Inclusion in this directory is not an endorsement.