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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
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Tracking Information
First Submitted Date November 7, 2018
First Posted Date November 21, 2018
Last Update Posted Date November 26, 2018
Actual Study Start Date November 1, 2018
Estimated Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 21, 2018)
  • 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.
Original Primary Outcome Measures
 (submitted: November 20, 2018)
  • 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)
  • To assess the safety of the contrast agent, PROHANCE [ Time Frame: up to .5 hours post-dose ]
    in terms of frequency, type and severity of adverse events
Change History Complete list of historical versions of study NCT03750188 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs
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
Brief 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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Central Nervous System Diseases
  • Central Nervous System Neoplasms
Intervention Drug: ProHance
0.1 mmol/kg ProHance intravenous injection
Other Name: Gadoteridol
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 20, 2018)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 30, 2019
Estimated Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Is male or female and was younger than 2 years of age at the time of the MRI with PROHANCE injection at the dose of 0.1 mmol/kg (±25% in volume administered).
  • Has demographic information, reason for the ProHance-enhanced MR examination, relevant medical history, final diagnosis, and safety data available.
  • Has documented known or highly suspected enhancing disease of CNS (brain/spine) and previously underwent a cranial or spinal MR examination requiring an injection of PROHANCE contrast agent.
  • Has both predose and postdose T1 SE/FSE and/or GRE and T2 SE/FSE, and FLAIR MR images (when available) for submission to Bracco or designee to be evaluated in a fully blinded read.
  • Has complete information on the imaging protocol used for the ProHance-enhanced MR exam including type of exam (brain or spine), MR scanner and field strength (1.0, 1.5 or 3.0 Tesla)
  • Has a documented dose of PROHANCE administered for their MRI exam and/or the volume (mL) and weight of the patient available to be used to calculate the exact dose of PROHANCE that was administered.

Exclusion Criteria:

• Exclude a patient from this study if the patient does not fulfill all of the inclusion criteria.

Sex/Gender
Sexes Eligible for Study: All
Ages up to 2 Years   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Anna Baratelle 609-514-2268 anna.baratelle@diag.bracco.com
Contact: Kathleen Bensel 609-514-2286 kathleen.bensel@diag.bracco.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03750188
Other Study ID Numbers PH-108
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Bracco Diagnostics, Inc
Study Sponsor Bracco Diagnostics, Inc
Collaborators Not Provided
Investigators
Study Director: Gianpaolo Pirovano, MD Bracco Diagnostics, Inc
PRS Account Bracco Diagnostics, Inc
Verification Date November 2018