Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06251830 |
| Other study ID # |
GR-2016-02361693 |
| Secondary ID |
GR-2016-02361693 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2018 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
IRCCS Fondazione Stella Maris |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
