Trial record 20 of 26 for:
"Abdominal Abscess"
Liver MRI With Primovist/Eovist in Pediatric Subjects Who Are Suspected or Have Focal Liver Lesions.
This study is ongoing, but not recruiting participants.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01043523
First received: January 4, 2010
Last updated: May 21, 2013
Last verified: May 2013
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Purpose
Medical records are reviewed to obtain information about the use of a MRI diagnostic imaging agent (contrast agent) called Primovist/Eovist in children older than 2 months and less than 18 years. Data that has been recorded in the child's medical records relating to the injection of Primovist/Eovist will be collected. Information will be collected from up to 2 weeks before the child received Primovist/Eovist until 12 months after the child received Primovist/Eovist. Copy of the child's MR images that were taken right before and after the child received Primovist/Eovist and all other reports (laboratory reports, other imaging reports, etc) that are part of the child's medical records during that time period will be collected.
| Condition | Intervention |
|---|---|
|
Liver Neoplasms Adenoma Carcinoma Liver Abscess |
Drug: Gadoxetic Acid Disodium (Primovist/Eovist, BAY86-4873) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | An Observational Study of the Administration of Eovist/Primovist in Pediatric Subjects (> 2 Months and Less Than 18 Years) Who Are Referred for a Routine Contrast Enhanced Liver MRI Because of Suspected or Known Focal Liver Lesions |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Additional diagnostic information obtained from the combined precontrast and postcontrast images as compared with the precontrast images. To be determined by an independent blinded read. [ Time Frame: When precontrast and postcontrast images are available for all enrolled subjects ] [ Designated as safety issue: No ]
- Additional safety information [ Time Frame: 24 hours pre Eovist/Primovist administration to 1 year post Eovist/Primovist administration ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- For the pre-vs.combined pre-and postcontrast images,comparison of any change in the diagnosis, diagnostic confidence and management/therapy; any malignant or nonmalignant lesions detected on the combined pre-and post-images not detected on the pre-images [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects ] [ Designated as safety issue: No ]
- For the postcontrast images only, the overall image quality [ Time Frame: When precontrast and postcontrast images are available from all enrolled subjects ] [ Designated as safety issue: No ]
- Serious Adverse Events collection [ Time Frame: End of Study (on average 1 year post Primovist/Eovist MRI) ] [ Designated as safety issue: Yes ]
Biospecimen Retention: None Retained
Pediatric subjects who have had a Eovist/Primovist enhanced MRI for known or suspected focal liver disease
| Enrollment: | 52 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Group 1 |
Drug: Gadoxetic Acid Disodium (Primovist/Eovist, BAY86-4873)
Subjects will have received Primovist/Eovist for liver MRI as part of their routine care at participating institutions and will be identified retrospectively from institution records
|
Eligibility| Ages Eligible for Study: | 2 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Pediatric subjects who have had a Primovist/Eovist enhanced MRI for known or suspected focal liver disease
Criteria
Inclusion Criteria:
- Age >2 months and <18 years of age at the time of the Primovist/Eovist enhanced MRI
- MRI with Primovist/Eovist due to suspected or known focal liver lesions
- Evaluable safety data
- Evaluable efficacy data: precontrast and postcontrast magnetic resonance (MR) images must be available for review
- If the above criteria are met, the principal investigator (PI) and/or designee will obtain a signed consent for medical records release including access to anonymized electronic copies of the pre- and post-Primovist/Eovist MRI scans, in accordance with local regulatory requirements in order for subjects to be enrolled in the study.
Exclusion Criteria:
- A subject will be excluded from this observational / retrospective study if the subject has previously been enrolled into this study. Subjects may only be entered once into this study, even if they have been imaged multiple times and for different indications.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043523
Locations
| United States, California | |
| Palo Alto, California, United States, 94304 | |
| United States, New York | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cinncinati, Ohio, United States, 45229 | |
| United States, Pennsylvania | |
| Hershey, Pennsylvania, United States, 17033 | |
| Italy | |
| Many Locations, Italy | |
| Japan | |
| Many Locations, Japan | |
| Singapore | |
| Many Locations, Singapore | |
| Taiwan | |
| Many Locations, Taiwan | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Global Medical Affairs Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT01043523 History of Changes |
| Other Study ID Numbers: | 13729 |
| Study First Received: | January 4, 2010 |
| Last Updated: | May 21, 2013 |
| Health Authority: | Singapore: Health Sciences Authority Italy: The Italian Medicines Agency Japan: Pharmaceuticals and Medical Devices Agency Taiwan: Department of Health United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Liver neoplasms Adenoma Liver cell carcinoma Hepatocellular Liver abscess |
Additional relevant MeSH terms:
|
Abdominal Abscess Abscess Adenoma Neoplasms Carcinoma Liver Abscess Liver Neoplasms Suppuration Infection |
Inflammation Pathologic Processes Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Liver Diseases Digestive System Diseases Digestive System Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 23, 2013