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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProHance | Drug | 0.1 mmol/kg ProHance intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Border delineation of lesions | Blinded reader will assess the border delineation of lesion based on a 5 point scale, none (0) - Excellent (4) | Immediately post dose - Day 1 |
| Visualization of internal morphology of lesions | Blinded reader will assess the visualization of internal morphology of the lesion(s) based on a 5 point scale, none (0) - Excellent (4) | Immediately post dose - Day 1 |
| Contrast enhancement of lesions | Blinded reader will assess the contrast enhancement of the lesion(s) based on a 5 point scale, none (0) - Excellent (4) | Immediately post dose- Day 1 |
| Number and percentage of subjects with ProHance Related Adverse Events | In terms of frequency, type and severity of adverse events Data collected, will consist of Screening Serum Creatinine value (mg/dL), If available, Vital signs (systolic blood pressure, diastolic blood pressure, heart rate, respiration rate) and ECG. | up to 2 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
• Exclude a patient from this study if the patient does not fulfill all of the inclusion criteria.
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The study will include patients younger than 2 years of age who have previously undergone MRI of the CNS (brain or spine) with PROHANCE at the dose of 0.1 mmol/kg as part of their clinical work-up.
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| Name | Affiliation | Role |
|---|---|---|
| Gianpaolo Pirovano, MD | Bracco Diagnostics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C062402 | gadoteridol |
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