Brain DiseasesNCT03023566
Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI
An observational study of Brain Diseases, run by Phoenix Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Brain Diseases
- What is being tested?
- Dotarem
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2017to 12 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population will consist of N = 250 pediatric patients (< 18 years) who are indicated for contrast enhanced MRI.
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI in Pediatric and Neonatal Patient Population (<18years)
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.
Read the 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.
- Conditions
- Brain Diseases
- Being tested
- Dotarem
- Keywords
- Dotarem, MRI, pediatric, safety, efficacy
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DotaremDrug
Also called gadoterate meglumine
Dotarem at dose of 0.1 mmol/kg of body weight (routine/standard of care)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Dotarem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 - 48 hours
Secondary outcomes (2)
Efficacy of enhanced MRI compared to unenhanced MRI
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
Measured: 24 - 48 hours
Assessment of adverse events (AEs)
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.
Measured: 24 hours (+ / - 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start9 Feb 2017
- Primary completion12 Nov 2017
- Study completion12 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Principal investigator, Jeffrey Miller, MD, Phoenix Children's Hospital
- Investigators
- Jeffrey H Miller, MD, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023566
- Sponsor's protocol ID
- PCH IRB#16-102
- Status last verified
- May 2022
- First submitted
- 12 Jan 2017
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-individual Open-label, Single Center Study to Compare Unenhanced MRI With Dotarem Enhanced MRI in Pediatric and Neonatal Patient Population (<18years)
- ClinicalTrials.gov ID
- NCT03023566
- Acronym / sponsor ID
- PCH IRB#16-102
- Conditions
- Brain Diseases
- Keywords
- Dotarem, MRI, pediatric, safety, efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 12 Nov 2017 (actual)
- Study completion
- 12 Nov 2017 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dotarem Enhanced MRI | – | Drug: DotaremAll 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). |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of N = 250 pediatric patients (< 18 years) who are indicated for contrast enhanced MRI.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DotaremAlso: gadoterate meglumineDotarem at dose of 0.1 mmol/kg of body weight (routine/standard of care) | Drug | Dotarem Enhanced MRI |
Primary outcome
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.
2 secondary outcomes
Efficacy of enhanced MRI compared to unenhanced MRI
Time frame: 24 - 48 hours
Assessment of adverse events (AEs)
Time frame: 24 hours (+ / - 4 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey H Miller, MD principal investigator
Phoenix Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Diseases, run by Phoenix Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall lesion visualization and characterization (time frame: 24 - 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022; AzTrials last refreshed its copy on 4 Nov 2026.