Post-marketing Safety Study in Participants of All Pathologies Who Receive Gadolinium-Based Contrast Agents (GBCAs) for Contrast-Enhanced Magnetic Resonance Imaging (MR) Examination

December 3, 2019 updated by: GE Healthcare

A Study of Pattern of Use for Gadolinium-Based Contrast Agents (GBCAs) in Patients Undergoing Contrast-Enhanced Magnetic Resonance (CE-MR) Examination - A Prospective, Multicenter, Observational Study

The purpose of this study is to prospectively collect data on the pattern of use for gadolinium-based contrast agents (GBCAs) in real-life setting with special reference to Clariscan after its commercial launch in Europe and in addition quality of images, diagnostic confidence and customer satisfaction will be assessed on a Likert scale by the local radiologist/technician and spontaneously reported immediate and delayed adverse events (AEs) to assess the effectiveness and safety profile of GBCAs in clinical practice respectively.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ludwigshafen, Germany, 67059
        • Radiology and Nuclear Medicine Ludwigshafen, Otto-Stabel Str. 2-4
  • Norway
      • Oslo, Norway, 0316
        • University of Oslo, Division of Radiology and Nuclear Medicine, P.O. Box 1072, Blindern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants routinely evaluated with CE-MR in one of 17 European radiology centres. Eligible centres will have Clariscan included on the formulary for Magnetic resonance (MR) examinations and have electronic record of cumulative data and are willing to report the cumulative data at the end of the recruitment period. Only one investigator per centre will be selected to perform the MR examination for that centre as part of the study.

Description

Inclusion Criteria: Participants may be included in the study if they meet all of the following criteria:

  • Participants of all ages and both male/females
  • Participants of all pathologies who require contrast-enhanced magnetic resonance (CE-MR) imaging as part of their diagnostic work up and the radiologist/physician has made the decision to use extracellular gadolinium-based contrast agents (GBCAs) as part of routine clinical practice
  • Participants Who Provide informed consent to participate in study

Exclusion Criteria:

  • Use of liver-specific GBCAs (Primovist and MultiHance when used for liver excretion properties)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Clariscan 0.5 mmol/ml
Participants will receive Clariscan 0.5 mmol/ml injection as apart of clinical practice at the medical discretion of the prescribing physician.
Drug: Clariscan
Clariscan 0.5 mmol/ml solution for injection will be administered as part of clinical practice according to the judgment of the site with regard to medical need.
All Gadolinium-Based Contrast Agents (GBCAs)
Participants will receive GBCA as part of clinical practice at the medical discretion of the prescribing physician.
Other: Gadolinium-Based Contrast Agents
All GBCAs will be selected by the sites and recorded as by the brand names.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pattern of Use of GBCAs in Magnetic Resonance Imaging (MRI) Centres
Time Frame: Up to 3 months
The Pattern of use will be assessed on summary data collected from: number of radiological procedures (including ultrasound, MR, computed tomography [CT] scan, fluoroscopy, X-ray, single-photon emission CT [SPECT], and positron emission tomography [PET] examinations), number of MR machines, number of enhanced and non-enhanced procedures, characteristics of the treated population (age, gender, BMI), dose indication, referring physician (seniority or specialty) performed by the study centre, investigator and patient-level variables. A qualitative analysis of these variables will be performed describing the overall pattern of use, referral pattern, and challenges in a radiological practice.
Up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Visualization of the Contrast-Enhanced Magnetic Resonance (CE-MR) Image, Based on the Local Radiologist Assessment
Time Frame: Post-image acquisition on Day 1
Quality of image will be assessed by the local reporting radiologist on a 4-point Likert scale. For cardiovascular magnetic resonance angiography (MRA), qualitative assessment will be performed by blinded readers and assess image quality on a scale of 1 to 4 as 1=poor image quality and blurring of the arterial segment; 2=fair image quality, inadequate arterial enhancement for confident diagnosis; 3=good image quality and arterial enhancement, adequate for confident diagnosis; 4=excellent image quality and arterial enhancement, for highly confident diagnosis. For Magnetic resonance imaging (MRI), characterisation of the lesion (or most representative lesion, i.e., enhancing and/or largest if there will be >1 lesion present) will be assessed on a 4-point scale as 1= poor, inadequate; 2= fair, partial; 3= good, adequate; 4= excellent.
Post-image acquisition on Day 1
Change in Diagnostic Confidence (Evaluated by Local Radiologist) in Pre-Contrast and Post-Contrast CE-MR Examination Results
Time Frame: Pre and post administration on Day 1
For each participant based on the most representative lesion. All available sequences (e.g., fluid attenuation inversion recovery [FLAIR], T2, and T1 with and without contrast administration) will be available for readers to review and evaluate. Before reviewing the CE-MR image, the radiologist will be asked to enter the confidence to make a diagnosis for the participant as a whole number between 0% to 100% based only on the non-enhanced image. The radiologist will then enter the diagnostic confidence as a whole number between 0% to 100% after the CE-MR scan results are read. This will be used to calculate the change in diagnostic confidence in this study by the local radiologist for all GBCAs including Clariscan.
Pre and post administration on Day 1
Customer Satisfaction Survey, Based on the Reports by the Local Nurse/Radiology Technician
Time Frame: Upto end of recruitment (upto 90 days)
Customer satisfaction survey was reported once per centre by MR nurse/technician from the investigator's staff - Quality of packaging including bottles, syringe, marking, pack size available. This will be recorded once for each GBCA used at the study centre as an overall impression and rated as: 1 = can be improved; 2 = good; 3 = excellent.
Upto end of recruitment (upto 90 days)
Percentage of Participants With Treatment-Related Adverse Events (AEs)
Time Frame: Up to 3 months
Up to 3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Visualization of the Contrast-Enhanced Magnetic Resonance (CE-MR) Image, Based on the Assessment by MR Experts
Time Frame: Within 18 months from study start date
The anonymised images will be blindly analysed by an expert MR radiologist panel to assess the quality of images. The first 50 images will be analysed in a 1:1 ratio for Clariscan and other GBCAs, i.e., the first consecutive 25 images for Clariscan and the first consecutive 25 images of the other GBCAs (excluding liver-specific GBCAs). This analysis will be performed at a later date and not part of the initial read out of the study.
Within 18 months from study start date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 11, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLA-17-01
  • EUPAS21473 (Registry Identifier: EU PAS Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Magnetic Resonance Imaging (MRI)

Clinical Trials on Clariscan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings