Neurodevelopmental DisordersNCT06251830
Increasing Diagnosis Rates While Reducing Examination Time: Can MR Fingerprinting Deliver on Its Promise?
An observational study of Neurodevelopmental Disorders and Neurodegenerative Diseases, run by IRCCS Fondazione Stella Maris at 2 sites in Italy.
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). Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders, Neurodegenerative Diseases, Brain Tumor
- What is being tested?
- MRI exam with Magnetic Resonance Fingerprinting
- How many people
- 610 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Sep 2018to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- contraindications to the MRI exam
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Azienda Ospedaliero Universitaria Pisana
Pisa, 56126
IRCCS Stella Maris
Pisa, 56128
About this study
Official title: Aumentare il Potere Diagnostico Riducendo la Durata Dell'Esame: MR Fingerprinting Soddisfa le Aspettative?
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.
Read the 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.
- Conditions
- Neurodevelopmental Disorders, Neurodegenerative Diseases, Brain Tumor, Multiple Sclerosis, Epilepsy
- Being tested
- MRI exam with Magnetic Resonance Fingerprinting
- Medical subject headings
- Neurodevelopmental Disorders, Neurodegenerative Diseases, Brain Neoplasms, Multiple Sclerosis, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI exam with Magnetic Resonance FingerprintingDiagnostic test
Acquisition of MRI data with technique "Magnetic Resonance Fingerprinting"
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients | Pediatric patients referred to the participating imaging centre for a standard MRI procedure. Receives: Diagnostic Test: MRI exam with Magnetic Resonance Fingerprinting | |
| Adult Patients | Adult patients referred to the participating imaging centre for a standard MRI procedure, with neurological signs and symptoms. Receives: Diagnostic Test: MRI exam with Magnetic Resonance Fingerprinting | |
| Healthy Controls | Adult healthy controls Receives: Diagnostic Test: MRI exam with Magnetic Resonance Fingerprinting |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRF diagnostic power
To evaluate diagnosis rates with MRF in pediatric patients and challenging adult populations
Measured: "Day 1" - Single time point (MRI examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Sep 2018
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana
- Responsible party
- Principal investigator, Mauro Costagli, IRCCS Fondazione Stella Maris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251830
- Sponsor's protocol ID
- GR-2016-02361693
- Other IDs
- GR-2016-02361693
- Status last verified
- Feb 2024
- First submitted
- 16 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aumentare il Potere Diagnostico Riducendo la Durata Dell'Esame: MR Fingerprinting Soddisfa le Aspettative?
- ClinicalTrials.gov ID
- NCT06251830
- Acronym / sponsor ID
- GR-2016-02361693
- Conditions
- Neurodevelopmental Disorders, Neurodegenerative Diseases, Brain Tumor, Multiple Sclerosis, Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients | – | Diagnostic Test: MRI exam with Magnetic Resonance FingerprintingPediatric patients referred to the participating imaging centre for a standard MRI procedure. |
| Adult Patients | – | Diagnostic Test: MRI exam with Magnetic Resonance FingerprintingAdult patients referred to the participating imaging centre for a standard MRI procedure, with neurological signs and symptoms. |
| Healthy Controls | – | Diagnostic Test: MRI exam with Magnetic Resonance FingerprintingAdult healthy controls |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- contraindications to the MRI exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI exam with Magnetic Resonance FingerprintingAcquisition of MRI data with technique "Magnetic Resonance Fingerprinting" | Diagnostic test | Adult Patients, Healthy Controls, Pediatric patients |
Primary outcome
MRF diagnostic power
Time frame: "Day 1" - Single time point (MRI examination)
To evaluate diagnosis rates with MRF in pediatric patients and challenging adult populations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorders and Neurodegenerative Diseases, run by IRCCS Fondazione Stella Maris at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRF diagnostic power (time frame: "Day 1" - Single time point (MRI examination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.