Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs
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|ClinicalTrials.gov Identifier: NCT03750188|
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 26, 2018
|Condition or disease||Intervention/treatment|
|Central Nervous System Diseases Central Nervous System Neoplasms||Drug: ProHance|
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.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||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|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||March 30, 2019|
|Estimated Study Completion Date :||May 30, 2019|
- Drug: ProHance
0.1 mmol/kg ProHance intravenous injectionOther Name: Gadoteridol
- Border delineation of lesions [ Time Frame: Immediately post dose - Day 1 ]Blinded reader will assess the border delineation of lesion based on a 5 point scale, none (0) - Excellent (4)
- Visualization of internal morphology of lesions [ Time Frame: Immediately post dose - Day 1 ]Blinded reader will assess the visualization of internal morphology of the lesion(s) based on a 5 point scale, none (0) - Excellent (4)
- Contrast enhancement of lesions [ Time Frame: Immediately post dose- Day 1 ]Blinded reader will assess the contrast enhancement of the lesion(s) based on a 5 point scale, none (0) - Excellent (4)
- Number and percentage of subjects with ProHance Related Adverse Events [ Time Frame: up to 2 hours post-dose ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750188
|Contact: Anna Baratelleemail@example.com|
|Contact: Kathleen Benselfirstname.lastname@example.org|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Maria Vittoria Spampinato, MD|
|Study Director:||Gianpaolo Pirovano, MD||Bracco Diagnostics, Inc|