Increasing Diagnosis Rates While Reducing Examination Time: Can MR Fingerprinting Deliver on Its Promise?
Aumentare il Potere Diagnostico Riducendo la Durata Dell'Esame: MR Fingerprinting Soddisfa le Aspettative?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Due to its unrivalled diagnostic and prognostic capabilities, as well as the absence of harmful effects from ionizing radiation, MRI is often the radiological method of choice in children. However, radiology units have to face the inability to produce motion-free images especially in young children, even more so in those affected by neurological or neuropsychiatric disorders. These children are often incapable of completely following verbal instructions and cannot remain still in the scanner for a full exam. To avoid uncontrolled motion and the anxiety derived from long examinations, the majority of young children are sedated. However, sedation represents an extra procedure, carrying its own possible adverse effects, procedural complications as well as additional costs. Producing diagnostic, artefact-free images in a short time in children without sedation is thus an unmet need. The investigators' first hypothesis is that MR Fingerprinting can be used in a number of cases to perform a fast and diagnostic exam in children without using sedation.
The advantages of a fast, motion-resistant quantitative scan are not limited to paediatrics but could see wide application.
Disorders of movement such as tremor-dominant Parkinson's disease and severe cognitive impairments such as Alzheimer's disease represent a big challenge when referred to MRI. Although MRI is not a major player in diagnosing such diseases, these patients often require an exam in order to exclude other pathologies with similar clinical manifestations and to diagnose or follow-up other concomitant conditions. Patients with expansive intracranial lesions or requiring frequent follow-up, like those affected by inflammatory disease of the central nervous system, need to undergo long and demanding procedures, and they can eventually get into significant distress. The image quality of standard MRI with these challenging patient groups is often poor, as they cannot lay still or are unable to follow instructions. The investigators' second hypothesis is that MRF can be used to increase diagnosis rates of exams in difficult adult populations, reducing the time spent in the scanner and thus reducing wasted procedures and cost, and increasing patient comfort.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pisa, Italy, 56126
- Azienda Ospedaliero Universitaria Pisana
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Pisa, Italy, 56128
- IRCCS Stella Maris
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Pediatric patients referred to the participating imaging centre for a standard MRI procedure.
Adult patients referred to the participating imaging centre for a standard MRI procedure, with neurological signs and symptoms.
Adult healthy controls.
Description
Inclusion Criteria:
- ability of understanding and speaking Italian;
- patients referred to the participating imaging centres for a standard MRI procedure;
- adult healthy controls.
For adult patients: inclusion criteria will comprise movement disorders, severe cognitive impairment, expansive intracranial lesions and inflammatory diseases of the central nervous system.
Exclusion Criteria:
- contraindications to the MRI exam
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Pediatric patients
Pediatric patients referred to the participating imaging centre for a standard MRI procedure.
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Acquisition of MRI data with technique "Magnetic Resonance Fingerprinting"
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Adult Patients
Adult patients referred to the participating imaging centre for a standard MRI procedure, with neurological signs and symptoms.
|
Acquisition of MRI data with technique "Magnetic Resonance Fingerprinting"
|
|
Healthy Controls
Adult healthy controls
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Acquisition of MRI data with technique "Magnetic Resonance Fingerprinting"
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MRF diagnostic power
Time Frame: "Day 1" - Single time point (MRI examination)
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To evaluate diagnosis rates with MRF in pediatric patients and challenging adult populations
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"Day 1" - Single time point (MRI examination)
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GR-2016-02361693 (Other Grant/Funding Number: Ministero della Salute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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