Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251830
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2024-01-16
Brief Title:
Increasing Diagnosis Rates While Reducing Examination Time Can MR Fingerprinting Deliver on Its Promise
Sponsor:
IRCCS Fondazione Stella Maris
Organization:
IRCCS Fondazione Stella Maris
Study Overview
Official Title:
Aumentare il Potere Diagnostico Riducendo la Durata DellEsame MR Fingerprinting Soddisfa le Aspettative
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Magnetic Resonance Imaging MRI is an excellent method for diagnosis and staging of brain disease However lengthy scan times and sensitivity to patient motion limit its efficacy To address this a novel method has recently been demonstrated called MR Fingerprinting MRF The investigators improved implementation of MRF featuring fully-quantitative data and a reduced sensitivity to patient motion can be used to acquire an anatomical exam in less than five minutes at a standard resolution The potential for wide applicability of this technique combined with an implied reduction in complexity and cost of MRI exams has generated wide interest However published studies have been limited to demonstrations in healthy volunteers and the effectiveness of MRF in the clinical practice has not yet been proven Here the investigators aim to assess the efficacy of MRF in performing diagnostic exams avoiding sedation in children and for increasing diagnosis rates in challenging adult patients
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 Parkinsons disease and severe cognitive impairments such as Alzheimers 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
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 Parkinsons disease and severe cognitive impairments such as Alzheimers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GR-2016-02361693 | OTHER_GRANT | Ministero della Salute | None |