search
Back to results

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

Primary Purpose

Diagnostic Self Evaluation, Central Nervous System Diseases

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dotarem (gadoterate meglumine)
Magnevist (gadopentetate dimeglumine)
Sponsored by
Guerbet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diagnostic Self Evaluation focused on measuring CNS, Contrast Agent, MRI, Dotarem, Magnevist

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • University of Alabama at Birmingham, UABMC
  • University Medical Center
  • University medical center
  • Desert Medical Imaging
  • Sunrise Clinical Research, Inc.
  • Children's Memorial Hospital
  • Precise Clinical Research Solutions
  • University of Louisville Hospital
  • Neurocare Center for Research
  • University of Michigan
  • QUEST Research Institute
  • Gruss Magnetic resonance Research Clinic
  • WestImage - Division of Research
  • Ohio State University
  • Medical University of South Carolina
  • University of Texas - Health Science Center
  • UTHSCSA
  • Clinical Trials of Texas, Inc.
  • University of Washington Medical Center
  • University of Wisconsin Hospital and Clinics
  • Centro de Diagnóstico
  • Hospital Italiano
  • TCBA
  • Univ.-institut f.Radiodiagnostik
  • Landesklinikum Tulln
  • Medical University of Vienna
  • Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
  • Universidade Federal de São Paulo / UNIFESP
  • Departamento de Neuroradiologia
  • Instituto de Neurocirugia Dr. Asenjo,
  • Hôpital Pellegrin
  • Hôpital Roger Salengro- CRHU de Lille
  • Hôpital Gui De Chauliac
  • Centre Hospitalier Sainte Anne
  • Radiologie A - Hôpital de la Milétrie
  • Fédération d'Imagerie Médicale,Hôpital Pontchaillou
  • University Hospital Charite
  • University Hospital Frankfurt
  • Krankenhaus Nordwest GmbH
  • University of Heidelberg
  • University of Leipzig
  • University Hospital Mannheim
  • University Hospital LMU Munich
  • Istituto di Radiologia
  • Neuroradiologia,II Università Di Napoli
  • Azienda Ospedaliera S. Andrea
  • Samsung Medical Center
  • Seoul National Unversity Hospital
  • Hospital Vall d´Hebron
  • Hospital Clinico Universitario San Carlos
  • Complejo Hospitalario Universitario de Vigo - Serviço de radiologia
  • University Department of Radiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Dotarem (gadoterate meglumine )

Magnevist (gadopentetate dimeglumine)

Dotarem 2 (gadoterate meglumine )

Arm Description

Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.

Dotarem and Magnevist were randomised as 2:1 ratio

Pediatric patients were assigned to Dotarem group only.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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

Full Information

First Posted
September 28, 2010
Last Updated
April 4, 2019
Sponsor
Guerbet
search

1. Study Identification

Unique Protocol Identification Number
NCT01211873
Brief Title
Safety and Efficacy Evaluation of DOTAREM® in MRI of Central Nervous System (CNS) Lesions
Acronym
SENTIO
Official Title
Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnostic Self Evaluation, Central Nervous System Diseases
Keywords
CNS, Contrast Agent, MRI, Dotarem, Magnevist

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dotarem (gadoterate meglumine )
Arm Type
Experimental
Arm Description
Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.
Arm Title
Magnevist (gadopentetate dimeglumine)
Arm Type
Active Comparator
Arm Description
Dotarem and Magnevist were randomised as 2:1 ratio
Arm Title
Dotarem 2 (gadoterate meglumine )
Arm Type
Experimental
Arm Description
Pediatric patients were assigned to Dotarem group only.
Intervention Type
Drug
Intervention Name(s)
Dotarem (gadoterate meglumine)
Other Intervention Name(s)
Dotarem
Intervention Description
0.1 mmol/kg by body weight, single IV injection
Intervention Type
Drug
Intervention Name(s)
Magnevist (gadopentetate dimeglumine)
Other Intervention Name(s)
Magnevist
Intervention Description
0.1 mmol/kg by body weight, single IV injection
Primary Outcome Measure Information:
Title
MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation
Description
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.
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Image Quality Score
Description
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.
Time Frame
up to 24 hours
Title
Diagnostic Confidence Score
Description
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).
Time Frame
up to 24 hours
Title
Number of Lesions
Description
The number of lesions for which observations could be made was calculated for each MRI modality and results are summarized per patient
Time Frame
up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Maravilla, MD
Organizational Affiliation
University of Wasington School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham, UABMC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University Medical Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
47404
Country
United States
Facility Name
University medical center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Desert Medical Imaging
City
Indian Wells
State/Province
California
ZIP/Postal Code
47404
Country
United States
Facility Name
Sunrise Clinical Research, Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Precise Clinical Research Solutions
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Neurocare Center for Research
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02446
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
QUEST Research Institute
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Gruss Magnetic resonance Research Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
WestImage - Division of Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45248
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
47404
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University of Texas - Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
47404
Country
United States
Facility Name
UTHSCSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
47404
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Centro de Diagnóstico
City
Buenos Aires
Country
Argentina
Facility Name
Hospital Italiano
City
Buenos Aires
Country
Argentina
Facility Name
TCBA
City
Buenos Aires
Country
Argentina
Facility Name
Univ.-institut f.Radiodiagnostik
City
Salzburg
Country
Austria
Facility Name
Landesklinikum Tulln
City
Tulln
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
Country
Austria
Facility Name
Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
City
São Paulo
Country
Brazil
Facility Name
Universidade Federal de São Paulo / UNIFESP
City
São Paulo
Country
Brazil
Facility Name
Departamento de Neuroradiologia
City
Santiago
Country
Chile
Facility Name
Instituto de Neurocirugia Dr. Asenjo,
City
Santiago
Country
Chile
Facility Name
Hôpital Pellegrin
City
Bordeaux
Country
France
Facility Name
Hôpital Roger Salengro- CRHU de Lille
City
Lille
Country
France
Facility Name
Hôpital Gui De Chauliac
City
Montpellier
Country
France
Facility Name
Centre Hospitalier Sainte Anne
City
Paris
Country
France
Facility Name
Radiologie A - Hôpital de la Milétrie
City
Poitiers
Country
France
Facility Name
Fédération d'Imagerie Médicale,Hôpital Pontchaillou
City
Rennes
Country
France
Facility Name
University Hospital Charite
City
Berlin
Country
Germany
Facility Name
University Hospital Frankfurt
City
Frankfurt/Main
Country
Germany
Facility Name
Krankenhaus Nordwest GmbH
City
Frankfurt
Country
Germany
Facility Name
University of Heidelberg
City
Heidelberg
Country
Germany
Facility Name
University of Leipzig
City
Leipzig
Country
Germany
Facility Name
University Hospital Mannheim
City
Mannheim
Country
Germany
Facility Name
University Hospital LMU Munich
City
Munich
Country
Germany
Facility Name
Istituto di Radiologia
City
Firenze
Country
Italy
Facility Name
Neuroradiologia,II Università Di Napoli
City
Napoli
Country
Italy
Facility Name
Azienda Ospedaliera S. Andrea
City
Roma
Country
Italy
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National Unversity Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hospital Vall d´Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos
City
Madrid
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo - Serviço de radiologia
City
Vigo
Country
Spain
Facility Name
University Department of Radiology
City
Cambridge
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs