Clinical trial · Observational

Retrospective Study of MRI in Pediatric Patients

The Safety and Efficacy of MULTIHANCE at the Dose of 0.10 mmol/kg in Magnetic Resonance Imaging of the Central Nervous System in Pediatric Patients Who Are Less Than 2 Years of Age

NCT02291822CI-TRIAL-00023130completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Collection of already existing data and images for patients \< 2 years of age having MultiHance administration for a MRI of the brain or spine. MR Images will be reviewed during a prospectively designed blinded reading of the images.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Central Nervous System Disease	—	UNRESOLVED	—
Central Nervous System Neoplasms	Central Nervous System Neoplasm	ONTOLOGY_EXACT	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Gadobenate Dimeglumine	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (3)

measure
Border delineation of lesions
timeFrame
Immediately post dose - Day 1
description
Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of lesion border delineation
measure
Visualization of internal morphology of lesions
timeFrame
Immediately post dose - Day 1
description
Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of visualization of internal morphology of the lesion(s)
measure
Contrast enhancement of lesions
timeFrame
Immediately post dose- Day 1
description
Unenhanced MRI and contrast enhanced MRI are superior to unenhanced MRI alone in terms of contrast enhancement of lesions

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 2 Years

Show eligibility criteria text

Inclusion Criteria:

* Male or female less than 2 years of age at the time of the MRI with MultiHance injection at a dose of 0.1 mmol/kg (± 25% in volume administered)
* Has available demographic and safety data
* Has documented known or highly suspected enhancing disease of the CNS (brain/spine) and previously underwent a cranial or spinal MR examination requiring an injection of MULTIHANCE contrast agent
* Has both pre and post dose T1 SE/FSE and/or GRE and T2 SE/FSE, and FLAIR MR images (when available) for submission to sponsor or designee to be evaluated in a fully blinded read
* Has a documented dose of MultiHance administered for their MRI exam and/or volume (mL) and weight of the patient available to be used to calculate the dose of MultiHance that was administered

Exclusion Criteria:

* Any patient who does not fulfill all of the inclusion criteria

References

Publications (0)

Data not yet available

No reference posted for this study.