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

NCT03455283 | Completed

• 2 other identifiers: CLA-17-01EUPAS21473
• Study Type: observational
• Target: 2,118
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Magnetic Resonance Imaging (MRI)

Outcome Measures

Primary Outcomes (1)

• Pattern of Use of GBCAs in Magnetic Resonance Imaging (MRI) Centres

  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 Outcomes (4)

• Quality of Visualization of the Contrast-Enhanced Magnetic Resonance (CE-MR) Image, Based on the Local Radiologist Assessment

  Post-image acquisition on Day 1

• Change in Diagnostic Confidence (Evaluated by Local Radiologist) in Pre-Contrast and Post-Contrast CE-MR Examination Results

  Pre and post administration on Day 1

• Customer Satisfaction Survey, Based on the Reports by the Local Nurse/Radiology Technician

  Upto end of recruitment (upto 90 days)

• Percentage of Participants With Treatment-Related Adverse Events (AEs)

  Up to 3 months

Other Outcomes (1)

• Quality of Visualization of the Contrast-Enhanced Magnetic Resonance (CE-MR) Image, Based on the Assessment by MR Experts

  Within 18 months from study start date

Study Arms (2)

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

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

Interventions

Clariscan DRUG

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.

Clariscan 0.5 mmol/ml

Gadolinium-Based Contrast Agents OTHER

All GBCAs will be selected by the sites and recorded as by the brand names.

All Gadolinium-Based Contrast Agents (GBCAs)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (2)

Radiology and Nuclear Medicine Ludwigshafen, Otto-Stabel Str. 2-4

Ludwigshafen, 67059, Germany

Location

University of Oslo, Division of Radiology and Nuclear Medicine, P.O. Box 1072, Blindern

Oslo, 0316, Norway

Location

MeSH Terms

Interventions

ferumoxtran-10

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 6, 2018
• Study Start: December 17, 2018
• Primary Completion: November 11, 2019
• Study Completion: November 11, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); NO (1)