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

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ClinicalTrials.gov Identifier: NCT03023566
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : March 15, 2017
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
Jeffrey Miller, MD, Phoenix Children's Hospital

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.

Condition or disease Intervention/treatment
Brain Diseases Drug: Dotarem

Detailed Description:

Phoenix Children's Hospital (PCH) performs approximately 200 contrast enhanced MRI procedures per month. Recently PCH changed its MRI contrast agent from the linear contrast agent Magnevist to the macrocyclic contrast agent Dotarem. 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 PCH.

The study is designed as a single center, open label comparison of unenhanced MRI with Dotarem enhanced MRI in pediatric patient population (<18years). The comparison will be performed intra-individually by 3 independent blinded radiologists. Overall, the study population will consist of 250 pediatric patients who are indicated for contrast enhanced MRI. The safety follow-up period will be 24 (+/- 4) hours post injection of Dotarem and includes the assessment of physical examinations and vital signs as well as the assessment of AEs.


Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI in Pediatric and Neonatal Patient Population (<18years)
Actual Study Start Date : February 9, 2017
Estimated Primary Completion Date : February 8, 2018
Estimated Study Completion Date : February 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Diseases

Group/Cohort Intervention/treatment
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
Dotarem at dose of 0.1 mmol/kg of body weight (routine/standard of care)
Other Name: gadoterate meglumine




Primary Outcome Measures :
  1. Overall lesion visualization and characterization [ Time Frame: 24 - 48 hours ]
    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.


Secondary Outcome Measures :
  1. Efficacy of enhanced MRI compared to unenhanced MRI [ Time Frame: 24 - 48 hours ]
    Efficacy of enhanced MRI compared to unenhanced MRI, based on (1) lesion counting, (2) signal intensity measurements, (3) image quality evaluation, and (4) diagnostic confidence (defined on 1-5 scale; 1= no confidence and 5 represents very high confidence

  2. Assessment of adverse events (AEs) [ Time Frame: 24 hours (+ / - 4 hours) ]
    Assessment of adverse events (AEs), volunteered, observed or elicited by vital signs, physical examination, and continuous monitoring of AEs from the beginning of Dotarem injection until end of the follow-up period of 24 (+ / - 4) hours after contrast administration.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT03023566


Contacts
Contact: Jeffrey H Miller, MD 602.933.1222 jhmiller@phoenixchildrens.com
Contact: Sarah N Wyckoff, PhD 602.933.1376 swyckoff@phoenixchildrens.com

Locations
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Jeffrey H Miller, MD    602-933-1222    jhmiller@phoenixchildrens.com   
Contact: Sarah N Wyckoff, PhD    602-933-1376    swyckoff@phoenixchildrens.com   
Sponsors and Collaborators
Phoenix Children's Hospital
Guerbet
Investigators
Principal Investigator: Jeffrey H Miller, MD Phoenix Children's Hospital

Responsible Party: Jeffrey Miller, MD, Staff Physician, Vice Chair of Radiology, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT03023566     History of Changes
Other Study ID Numbers: PCH IRB#16-102
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Jeffrey Miller, MD, Phoenix Children's Hospital:
Dotarem
MRI
pediatric
safety
efficacy

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases