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.
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
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.
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- 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.
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
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
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
Argentina3 sites
Centro de Diagnóstico
Buenos Aires
Hospital Italiano
Buenos Aires
TCBA
Buenos Aires
Austria3 sites
Univ.-institut f.Radiodiagnostik
Salzburg
Landesklinikum Tulln
Tulln
Medical University of Vienna
Vienna
Italy3 sites
Istituto di Radiologia
Florence
Neuroradiologia,II Università Di Napoli
Naples
Azienda Ospedaliera S. Andrea
Roma
Spain3 sites
Hospital Vall d´Hebron
Barcelona
Hospital Clinico Universitario San Carlos
Madrid
Complejo Hospitalario Universitario de Vigo - Serviço de radiologia
Vigo
Brazil2 sites
Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo
Universidade Federal de São Paulo / UNIFESP
São Paulo
Chile2 sites
Departamento de Neuroradiologia
Santiago
Instituto de Neurocirugia Dr. Asenjo,
Santiago
South Korea2 sites
Samsung Medical Center
Seoul
Seoul National Unversity Hospital
Seoul
About this study
Official title: Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.
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 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®.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ken Maravilla, MD, Principal investigator, University of Wasington School of Medicine
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