Diagnostic Self EvaluationPhase 3SENTIONCT01211873

Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions

A Phase 3 study testing Dotarem (gadoterate meglumine) and Magnevist (gadopentetate dimeglumine) in people with Diagnostic Self Evaluation and Central Nervous System Diseases, run by Guerbet at 52 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to look at the safety (what are the side effects)and efficacy (how well does it work) of Dotarem® when used in taking images of the brain / spine. The results will be compared to the results of MRI taken without Dotarem. Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Diagnostic Self Evaluation, Central Nervous System Diseases
What is being tested?: Dotarem (gadoterate meglumine) and Magnevist (gadopentetate dimeglumine)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 416 participants
Where: 52 sitesin 11 countries
Study dates: Sep 2010to Nov 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Adult subject and pediatric subjects (aged greater than or equal to two (2) years).
Is referred for a contrast-enhanced MRI of the CNS based on the results of a previous imaging procedure.
Female of childbearing potential patients must have effective contraception (contraceptive pill or intra-uterine device) or be surgically sterilized or post-menopausal (minimum 12 months amenorrhea), or have a documented negative urine pregnancy test within 24 hours prior to study MRI.
Has been fully informed about the study, and has consented to participate.

Who cannot join

Having acute or chronic grade IV or V renal insufficiency.
Known class III/IV congestive heart failure.
Suffering from long QT syndrome.
Unstable health condition or circumstances (e.g. suffering from severe claustrophobia).
Having any contraindications to MRI such as a pace-maker, magnetic material or any other conditions that would preclude proximity to a strong magnetic field.
Known allergy to Gadolinium chelates.

Show all 12Show fewer

Having received any contrast agent within 3 days prior to study contrast administration, or is scheduled to receive any contrast agent within 24 hours after the study contrast administration.
Pregnant, breast feeding, or planning to become pregnant during the trial.
Previously participated in this trial.
Having participated within 30 days in another clinical trial involving an investigational drug.
Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits.
Inability or unwillingness to cooperate with the requirements of this trial.

Trial locations and contacts

52 sites in 11 countries.

Country

City, postcode or hospital

52 sites in 11 countries

United States20 sites

University of Michigan
Ann Arbor, Michigan, 48109
University of Alabama at Birmingham, UABMC
Birmingham, Alabama, 35233
Neurocare Center for Research
Brookline, Massachusetts, 02446
Medical University of South Carolina
Charleston, South Carolina, 29425
Children's Memorial Hospital
Chicago, Illinois, 60614
WestImage - Division of Research
Cincinnati, Ohio, 45248
Ohio State University
Columbus, Ohio, 47404
QUEST Research Institute
Farmington Hills, Michigan, 48334
Sunrise Clinical Research, Inc.
Hollywood, Florida, 33021
Desert Medical Imaging
Indian Wells, California, 47404
University of Louisville Hospital
Louisville, Kentucky, 40202
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Gruss Magnetic resonance Research Clinic
New York, New York, 10461
University of Texas - Health Science Center
San Antonio, Texas, 47404
UTHSCSA
San Antonio, Texas, 47404
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
University of Washington Medical Center
Seattle, Washington, 98195
Precise Clinical Research Solutions
Topeka, Kansas, 66604
University Medical Center
Tucson, Arizona, 47404
University medical center
Tucson, Arizona, 85724

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Germany7 sites

University Hospital Charite
Berlin
Krankenhaus Nordwest GmbH
Frankfurt
University Hospital Frankfurt
Frankfurt am Main
University of Heidelberg
Heidelberg
University of Leipzig
Leipzig
University Hospital Mannheim
Mannheim
University Hospital LMU Munich
Munich

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France6 sites

Hôpital Pellegrin
Bordeaux
Hôpital Roger Salengro- CRHU de Lille
Lille
Hôpital Gui De Chauliac
Montpellier
Centre Hospitalier Sainte Anne
Paris
Radiologie A - Hôpital de la Milétrie
Poitiers
Fédération d'Imagerie Médicale,Hôpital Pontchaillou
Rennes

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Argentina3 sites

Centro de Diagnóstico
Buenos Aires
Hospital Italiano
Buenos Aires
TCBA
Buenos Aires

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Austria3 sites

Univ.-institut f.Radiodiagnostik
Salzburg
Landesklinikum Tulln
Tulln
Medical University of Vienna
Vienna

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Italy3 sites

Istituto di Radiologia
Florence
Neuroradiologia,II Università Di Napoli
Naples
Azienda Ospedaliera S. Andrea
Roma

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Spain3 sites

Hospital Vall d´Hebron
Barcelona
Hospital Clinico Universitario San Carlos
Madrid
Complejo Hospitalario Universitario de Vigo - Serviço de radiologia
Vigo

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Brazil2 sites

Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo
Universidade Federal de São Paulo / UNIFESP
São Paulo

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Chile2 sites

Departamento de Neuroradiologia
Santiago
Instituto de Neurocirugia Dr. Asenjo,
Santiago

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South Korea2 sites

Samsung Medical Center
Seoul
Seoul National Unversity Hospital
Seoul

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United Kingdom1 site

University Department of Radiology
Cambridge

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About this study

Official title: Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.

Read the detailed description

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Dotarem®. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Dotarem® when used for taking images of the brain and spine. The results of the MRI will be compared to the results of images taken without Dotarem®.

Conditions: Diagnostic Self Evaluation, Central Nervous System Diseases
Being tested: Dotarem (gadoterate meglumine), Magnevist (gadopentetate dimeglumine)
Keywords: CNS, Contrast Agent, MRI, Dotarem, Magnevist
Medical subject headings: Central Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dotarem (gadoterate meglumine)Drug
Also called Dotarem
0.1 mmol/kg by body weight, single IV injection
Magnevist (gadopentetate dimeglumine)Drug
Also called Magnevist
0.1 mmol/kg by body weight, single IV injection

Study groups in NCT01211873
Study group	Role	What they receive
Dotarem (gadoterate meglumine )	Experimental	Dotarem and Magnevist were randomised as 2:1 ratio for adult patients. Receives: Drug: Dotarem (gadoterate meglumine)
Magnevist (gadopentetate dimeglumine)	Active comparator	Dotarem and Magnevist were randomised as 2:1 ratio Receives: Drug: Magnevist (gadopentetate dimeglumine)
Dotarem 2 (gadoterate meglumine )	Experimental	Pediatric patients were assigned to Dotarem group only. Receives: Drug: Dotarem (gadoterate meglumine)

What is being measured

The primary outcome is the main question the study is designed to answer.

MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation
To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization.
Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. "Pre" refers to unenhanced MRI. "PAIRED" refer to combined unenhanced and enhanced MRI.
The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0.
Measured: up to 24 hours

Secondary outcomes (3)

Image Quality Score
Image quality was evaluated for each lesion according to a 3-point scale with the following grades; poor (1), fair (2) or good (3), and an overall score per patient was calculated. At patient level, the maximum score is 3, minimum score is 1. Higher scores mean a better image quality.
Measured: up to 24 hours
Diagnostic Confidence Score
Level of diagnostic confidence when evaluating the MRI modalities was graded using a 5-point scale as nil (1), poor (2), moderate (3), high (4) and excellent (5).
Measured: up to 24 hours
Number of Lesions
The number of lesions for which observations could be made was calculated for each MRI modality and results are summarized per patient
Measured: up to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2010Nov 2011

First posted30 Sep 2010 (estimated)
Study startSep 2010
Primary completionNov 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diagnostic Self EvaluationStudies 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: Interventional
Phase: Phase 3
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 416 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01211873
Sponsor's protocol ID: DGD-44-050
Acronym: SENTIO
Status last verified: Apr 2019
First submitted: 28 Sep 2010
Last updated: 18 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.
ClinicalTrials.gov ID: NCT01211873
Acronym / sponsor ID: SENTIO / DGD-44-050
Conditions: Diagnostic Self Evaluation, Central Nervous System Diseases
Keywords: CNS, Contrast Agent, MRI, Dotarem, Magnevist
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 416 participants (actual)
Lead sponsor: GuerbetIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 30 Sep 2010 (estimated)
Results: Posted 29 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Dotarem (gadoterate meglumine )	Experimental	Drug: Dotarem (gadoterate meglumine)Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.
Magnevist (gadopentetate dimeglumine)	Active comparator	Drug: Magnevist (gadopentetate dimeglumine)Dotarem and Magnevist were randomised as 2:1 ratio
Dotarem 2 (gadoterate meglumine )	Experimental	Drug: Dotarem (gadoterate meglumine)Pediatric patients were assigned to Dotarem group only.

Who may qualify

Ages: 2 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Adult subject and pediatric subjects (aged greater than or equal to two (2) years).
Is referred for a contrast-enhanced MRI of the CNS based on the results of a previous imaging procedure.
Female of childbearing potential patients must have effective contraception (contraceptive pill or intra-uterine device) or be surgically sterilized or post-menopausal (minimum 12 months amenorrhea), or have a documented negative urine pregnancy test within 24 hours prior to study MRI.
Has been fully informed about the study, and has consented to participate.

Key exclusion criteria (12 listed)

Having acute or chronic grade IV or V renal insufficiency.
Known class III/IV congestive heart failure.
Suffering from long QT syndrome.
Unstable health condition or circumstances (e.g. suffering from severe claustrophobia).
Having any contraindications to MRI such as a pace-maker, magnetic material or any other conditions that would preclude proximity to a strong magnetic field.

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
Dotarem (gadoterate meglumine)Also: Dotarem0.1 mmol/kg by body weight, single IV injection	Drug	Dotarem (gadoterate meglumine ), Dotarem 2 (gadoterate meglumine )
Magnevist (gadopentetate dimeglumine)Also: Magnevist0.1 mmol/kg by body weight, single IV injection	Drug	Magnevist (gadopentetate dimeglumine)

Primary outcome

MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation
Time frame: up to 24 hours
To demonstrate the superiority of combined unenhanced and Dotarem enhanced MRI (PAIRED) compared to unenhanced MRI (PRE) in terms of lesion visualization. Unenhanced MRI refers to MRI before administration of contrast agent. Enhanced MRI refers to MRI after contrast agent injection. "Pre" refers to unenhanced MRI. "PAIRED" refer to combined unenhanced and enhanced MRI. The measure used a specific scale with 3-point levels to assess lesion visualization. At lesion level, the scale range is from 0 through 1 to 2. Score 0 means a worse outcome and score 2 means a better outcome. Patient score is the sum of all lesion scores. Up to 5 of the largest representative lesions were assessed. At patient level, the maximum score is 10, minimum score is 0.

3 secondary outcomes

Image Quality Score
Time frame: up to 24 hours
Diagnostic Confidence Score
Time frame: up to 24 hours
Number of Lesions
Time frame: up to 24 hours

Results and safety

Results posted to the registry on 29 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dotarem (Gadoterate Meglumine)	245	240
Magnevist (Gadopentetate Dimeglumine)	119	117
Dotarem 2 (Gadoterate Meglumine)	38	36

Primary outcome: MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation

Time frame: up to 24 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Dotarem (Gadoterate Meglumine) - PRE n = 224	Dotarem (Gadoterate Meglumine) - PAIRED n = 235
Border Delineation Blinded Reader 1	1.06 (1.23)	3.30 (2.64)
Border Delineation Blinded Reader 2	1.62 (1.43)	4.49 (2.94)
Border Delineation Blinded Reader 3	1.43 (1.29)	2.54 (2.30)
Internal Morphology Blinded Reader 1	0.97 (1.05)	3.70 (2.63)
Internal Morphology Blinded Reader 2	1.76 (1.24)	4.49 (2.93)
Internal Morphology Blinded Reader 3	1.45 (1.13)	2.93 (2.30)
Contrast Enhancement Blinded Reader 1	0.01 (0.20)	3.11 (2.52)
Contrast Enhancement Blinded Reader 2	0.01 (0.15)	3.73 (2.67)

Dotarem (Gadoterate Meglumine) - PRE vs Dotarem (Gadoterate Meglumine) - PAIRED: p <0.001, Regression, Logistic

Population analysed: The primary analysis was performed at the patient level using off-site readings by 3 readers. The number of participants for analysis depended on the number of evaluable cases (PRE and PAIRED) determined by each reader. Only adult participants were included in this data set.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from patient consent signature to the end of the last visits, maximum duration is 29 days.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dotarem (Gadoterate Meglumine )	0 of 240 (0%)	12 of 240 (5%)	0 of 240
Magnevist (Gadopentetate Dimeglumine)	1 of 117 (0.9%)	9 of 117 (7.7%)	0 of 117
Dotarem 2 (Gadoterate Meglumine )	1 of 38 (2.6%)	8 of 38 (21.1%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Ken Maravilla, MD principal investigator

University of Wasington School of Medicine

52 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Germany, France, Argentina, Austria and 6 more countries. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01211873.

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 18 Apr 2019.