Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI

NCT03023566 | Completed FDA Drug

• 1 other identifier: PCH IRB#16-102
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate safety and efficacy of Dotarem enhanced MRI in pediatric and neonatal population who are referred for contrast enhanced MRI at Phoenix Children's Hospital.

Conditions

Brain Diseases

Keywords

Dotarem; MRI; pediatric; safety; efficacy

Outcome Measures

Primary Outcomes (1)

• Overall lesion visualization and characterization

  Overall lesion visualization and characterization, based on assessment of (1) lesion border delineation, (2) internal morphology and (3) degree of contrast enhancement. All images from "Pre" (unenhanced MRI) and "Paired" (unenhanced + enhanced) MRI will be evaluated independently by the 3 independent readers and are rated on a 3-point scale as unevaluable (0), seen but imperfectly (1) or seen completely/perfectly (2). The primary statistical analysis compared unenhanced MRI to combined MRI. The efficacy of Dotarem is expected to be demonstrated for at least 2 out of 3 readers independently meeting a statistically significant positive difference between the mean "Paired" score and the mean "Pre" score at patient level for each co primary endpoints.

  24 - 48 hours

Secondary Outcomes (2)

• Efficacy of enhanced MRI compared to unenhanced MRI

  24 - 48 hours

• Assessment of adverse events (AEs)

  24 hours (+ / - 4 hours)

Study Arms (1)

Dotarem Enhanced MRI

All pediatric patients (\< 18 years) scheduled for clinically indicated contrast enhanced MRI (Brain MRI with/without contrast) will receive a single IV bolus injection of Dotarem at a dose of 0.1 mmol/kg bw at a flow rate of 1-2 mL/sec followed by saline flush (routine/ standard of care).

Drug: Dotarem

Interventions

Dotarem DRUG

Dotarem at dose of 0.1 mmol/kg of body weight (routine/standard of care)

Also known as: gadoterate meglumine

Dotarem Enhanced MRI

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population will consist of N = 250 pediatric patients (\< 18 years) who are indicated for contrast enhanced MRI.

You may qualify if:

• Any patient under 18 years of age who is scheduled for contrast enhanced MRI examination as part of their standard of care.
• Patients who are willing to undergo contrast enhanced MRI procedure
• Patients who are willing to comply with the study procedures (e.g. being followed-up for 24 hours after MRI procedure).
• Patients who have given their fully informed and written consent voluntarily.

You may not qualify if:

• Patients receiving an MRI exam without contrast.
• Patients who are pregnant, lactating or who are \> 11 years old and have not had a negative urine pregnancy test the same day as administration of Dotarem. The manufacturer's instructions for performing the urinary pregnancy test are to be followed.
• Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study.
• Patients with a Glomerular Filtration Rate (GFR) \< 30.
• Having received any investigational drug within 30 days prior to entering this study or who are planned to receive any investigational drug during the 24 (+ / - 4) hour safety follow-up period.
• Not being able to remain lying down for at least 45 - 60 min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
• Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents .
• Patients who have received any other contrast medium within 24 hours prior to Dotarem injection or are scheduled to receive any other contrast medium within the follow-up period.
• Being clinically unstable and whose clinical course during the 24 (+ / - 4) hours observation period is unpredictable.
• Being scheduled for, or likely to require, any surgical intervention within 24 hours before or within the follow-up period.
• Having any contraindication to MRI examination (e.g. pacemaker, recent wound clips, and severe claustrophobia).
• Having been previously enrolled in this study.

Sponsors & Collaborators

• Phoenix Children's Hospital: lead
• Guerbet: collaborator

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

MeSH Terms

Conditions

Brain Diseases

Interventions

gadoterate meglumine

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jeffrey H Miller, MD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician, Vice Chair of Radiology

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 18, 2017
• Study Start: February 9, 2017
• Primary Completion: November 12, 2017
• Study Completion: November 12, 2017
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)