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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

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.

Condition or disease Intervention/treatment
Central Nervous System Diseases Central Nervous System Neoplasms Drug: ProHance

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.


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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Gadoteridol


Intervention Details:
  • Drug: ProHance
    0.1 mmol/kg ProHance intravenous injection
    Other Name: Gadoteridol


Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  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.



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

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


Contacts
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Contact: Anna Baratelle 609-514-2268 anna.baratelle@diag.bracco.com
Contact: Kathleen Bensel 609-514-2286 kathleen.bensel@diag.bracco.com

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Maria Vittoria Spampinato, MD         
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
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Study Director: Gianpaolo Pirovano, MD Bracco Diagnostics, Inc

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Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT03750188     History of Changes
Other Study ID Numbers: PH-108
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bracco Diagnostics, Inc:
CNS
MRI
ProHance
Gadoteridol
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Central Nervous System Diseases
Nervous System Diseases
Neoplasms by Site
Neoplasms