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Completed

NCT Number: NCT01211873

Safety and Efficacy Evaluation of DOTAREM® in MRI of 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.

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Key information

Conditions

Diagnostic Self Evaluation Central Nervous System Diseases Nervous System Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Diagnóstico, Buenos Aires, Argentina

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About this study

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®.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dotarem (gadoterate meglumine)

Drug

0.1 mmol/kg by body weight, single IV injection

Other names: Dotarem

Magnevist (gadopentetate dimeglumine)

Drug

0.1 mmol/kg by body weight, single IV injection

Other names: Magnevist

Primary outcomes

  1. 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.

Secondary outcomes

  1. Image Quality Score

    Time frame: up to 24 hours

    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.

  2. Diagnostic Confidence Score

    Time frame: up to 24 hours

    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).

  3. Number of Lesions

    Time frame: up to 24 hours

    The number of lesions for which observations could be made was calculated for each MRI modality and results are summarized per patient

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

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

Acronym: SENTIO

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 30, 2010
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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