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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01211873
First received: September 28, 2010
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diagnostic Self Evaluation
Central Nervous System Diseases
Drug: Dotarem (gadoterate meglumine)
Drug: Magnevist (gadopentetate dimeglumine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Safety and Efficacy Evaluation of DOTAREM® in Magnetic Resonance Imaging (MRI) in Patients With Central Nervous System (CNS) Lesions.

Resource links provided by NLM:


Further study details as provided by Guerbet:

Primary Outcome Measures:
  • MRI Lesion Visualization (Border Delineation, Internal Morphology and Contrast Enhancement) at Patient Level for Both "Pre" and "Paired" Evaluation, Each Lesion is Scored With 3-point Scales. [ Time Frame: up to 24 hours as the safety is assessed till 24 hours after injection ] [ Designated as safety issue: No ]

    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. At patient level, the maximum score is 10, minimum score is 0.



Secondary Outcome Measures:
  • The Quality of Images on 3-point Scale: Poor, Fair or Good. [ Time Frame: up to 24 hours as the safety is assessed till 24 hours after injection ] [ Designated as safety issue: No ]
  • Level of Diagnostic Confidence on 5-point Scale Ranging From Nil to Excellent With Poor, Moderate and High as Intermediate Grades. [ Time Frame: up to 24 hours as the safety is assessed till 24 hours after injection ] [ Designated as safety issue: No ]
  • Number of Lesions With MRI Signal Intensity Changes After Contrast Agent Injection. [ Time Frame: up to 24 hours as the safety is assessed till 24 hours after injection ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability. [ Time Frame: up to 29 days ] [ Designated as safety issue: Yes ]
  • Measure Vital Signs (Supine Systolic and Diastolic Blood Pressures, Pulse). [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]
  • Measure ECG [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]
  • Injection-site Tolerance on the Visual Analog Scale From 0 (no Pain) to 10 (Maximal Pain). [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]
  • Measure Blood Sample. [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 416
Study Start Date: September 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dotarem (gadoterate meglumine )
Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.
Drug: Dotarem (gadoterate meglumine)
0.1 mmol/kg by body weight, single IV injection
Other Name: Dotarem
Active Comparator: Magnevist (gadopentetate dimeglumine)
Dotarem and Magnevist were randomised as 2:1 ratio
Drug: Magnevist (gadopentetate dimeglumine)
0.1 mmol/kg by body weight, single IV injection
Other Name: Magnevist
Experimental: Dotarem 2 (gadoterate meglumine )
Pediatric patients were assigned to Dotarem group only.
Drug: Dotarem (gadoterate meglumine)
0.1 mmol/kg by body weight, single IV injection
Other Name: 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®.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211873

  Show 52 Study Locations
Sponsors and Collaborators
Guerbet
Investigators
Principal Investigator: Ken Maravilla, MD University of Wasington School of Medicine
  More Information

No publications provided

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01211873     History of Changes
Other Study ID Numbers: DGD-44-050
Study First Received: September 28, 2010
Results First Received: July 25, 2013
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Guerbet:
CNS
Contrast Agent
MRI
Dotarem
Magnevist

Additional relevant MeSH terms:
Central Nervous System Diseases
Nervous System Diseases
Gadobenic acid
Gadolinium DTPA
Gadoterate meglumine
Meglumine
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014