DementiaNCT04154254
Applying PET/MR for Dementia Applications
A study testing PET/MR in people with Dementia, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Dementia is a common disorder affecting about 50 million people worldwide with nearly 10 million cases every year . It is characterized by cognitive impairments as well as behavior disabilities. Cognitive impairments include difficulties with memory, attention, language and other higher cortical functions. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Dementia
- What is being tested?
- PET/MR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2020to 10 Jan 2022
- Phase
- Interventional
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over the age of 18 with diagnosed conditions that might result in dementia or with diagnosed dementia in different stages.
Who cannot join
- Patients younger than 18 years
- pregnancy
- contraindication to MRI or to intravenous gadolinium injection.
About this study
Dementia is a common disorder affecting about 50 million people worldwide with nearly 10 million cases every year . It is characterized by cognitive impairments as well as behavior disabilities. Cognitive impairments include difficulties with memory, attention, language and other higher cortical functions. Behavior disabilities may include apathy, aggressive behavior, hallucinations and changes in social interaction. The most common cause of dementia is Alzheimer disease (AD). To plan a proper treatment for the patient it is critical to evaluate accurately the type of dementia as well as obtain the earliest diagnosis possible. However, accurate differential diagnosis in dementia poses difficulties due overlapping phenotypes and limited understanding of the mechanism and pathologies . Diagnosis of the dementia is performed based on the combination of clinical symptoms and biomarkers that include imaging, genetic biomarkers, cerebrospinal fluid (CSF), and other objective markers of disease . The two main modalities used for dementia imaging are Magnetic Resonance Imaging (MRI) and molecular imaging including Single Photon Emission Tomography (SPECT) and Positron Emission Tomography (PET). MRI is performed with various of contrasts such as high resolution T1- weighted, T2- weighted and Diffusion Tensor Imaging (DTI) and functional MRI (fMRI) [2]. These methods give information about morphological modifications in the brain and atrophy characterizing the specific dementia type. In addition brain perfusion and diffusion pattern and assessment of the changing un the resting state functional connectivity network of the brain can be studied with MRI. PET with different tracer molecules allow diagnosis of metabolism pattern in the brain (18F-FDG-PET), modifications in the neurotransmitter system and detection of brain plaques associated with dementia such as amyloid β or Tau aggregates . Data acquired from both modalities allow the reliable and differential diagnosis, prediction of pre-dementia stages, monitoring therapy response and additional research information regarding the mechanism of the condition.
Read the detailed description
Simultaneous measurements of PET and MR together as is recently became possible have allow spatial and temporal correlation between the two modalities opening a window of opportunities that was not available so far. The first practical advantage is because most neurological patients should go through both MRI and PET scans. Allowing both scans in the occasion significantly increase patient comfort. Furthermore, the simultaneous scans in contrast to sequential scans allow correlation between PET and MR informaiton without the concern of pathological brain modifications between the scans. Currently PET is performed combined with CT, which is superior to MR in the field of brain images. MR high soft tissue resolution as well as extra information it may provide regarding brain perfusion, diffusion, metabolic parameters etc., make the MR a far better modality for brain imaging than CT. In addition, the combined tool allow leveraging MR data to improve PET data quantification. PET issues such as motion correction, partial volume effect and correct localization of the tracer in the brain anatomy that cause PET image degradation and lower accuracy and robustness of PET quantitative parameters, can be solved by integrating MR data into the analysis. Several recently published articles have demonstrated different correction approaches for motion correction and partial volume effect showing an improvement in the PET images both visually and quantitatively . PET attenuation correction using MR data have also been studied, however this matter still need to be resolved. PET/MR for neurological conditions, in general, and specifically for conditions resulting in dementia, is a promising application with a large variety of research opportunities and its abilities need to be explored. Optimization of the acquisition protocols and even more so, the analysis and quantification protocols still need to be performed and will be the focus of this study.
- Conditions
- Dementia
- Being tested
- PET/MR
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRDiagnostic test
The PET will be performed with one of the following tracers: 18F-FDG, 18F-DOPA or 18F-flutemetamol (Vizamyl). Proper tracer will be determined by the physician according to the condition. Patients that will agree, will be asked to perform two scans each with different tracer. The 3 tesla magnet of the MRI should allow acquisition of several contrasts within a reasonable time frame. The protocol will include T1 and T2-weighted images, perfusion and diffusion images. Images will be analyzed visually and quantitatively. Quantitative analysis will include MR parameters such as DWI apparent diffusion coefficient (ADC) and PET quantitative metabolic data such as standard uptake values (SUV), metabolic tumor volume (MTV), and total lesion glycolysis (TLG). Hidden image parameters will also be extracted for texture analysis purposes. Quantitative data will be correlated to clinical and pathological data to check accuracy, specificity and sensitivity.
| Study group | Role | What they receive |
|---|---|---|
| Dementia Patients | Experimental | Not described Receives: Diagnostic Test: PET/MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who preformed PET/MR for dementia applications
Optimization of brain acquisition protocols and reconstruction (with focus on attenuation correction algorithm) for patients with conditions causing dementia.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start10 Jan 2020 (estimated)
- Primary completion10 Mar 2021 (estimated)
- Study completion10 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154254
- Sponsor's protocol ID
- TASMC-19-ES-0586-CTIL
- Status last verified
- Nov 2019
- First submitted
- 29 Oct 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying PET/MR for Dementia Applications
- ClinicalTrials.gov ID
- NCT04154254
- Acronym / sponsor ID
- TASMC-19-ES-0586-CTIL
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 10 Jan 2020 (estimated)
- Primary completion
- 10 Mar 2021 (estimated)
- Study completion
- 10 Jan 2022 (estimated)
- First posted
- 6 Nov 2019 (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.
Dementia is a common disorder affecting about 50 million people worldwide with nearly 10 million cases every year . It is characterized by cognitive impairments as well as behavior disabilities. Cognitive impairments include difficulties with memory, attention, language and other higher cortical functions. Behavior disabilities may include apathy, aggressive behavior, hallucinations and changes in social interaction. The most common cause of dementia is Alzheimer disease (AD). To plan a proper treatment for the patient it is critical to evaluate accurately the type of dementia as well as obtain the earliest diagnosis possible. However, accurate differential diagnosis in dementia poses difficulties due overlapping phenotypes and limited understanding of the mechanism and pathologies . Diagnosis of the dementia is performed based on the combination of clinical symptoms and biomarkers that include imaging, genetic biomarkers, cerebrospinal fluid (CSF), and other objective markers of disease . The two main modalities used for dementia imaging are Magnetic Resonance Imaging (MRI) and molecular imaging including Single Photon Emission Tomography (SPECT) and Positron Emission Tomography (PET). MRI is performed with various of contrasts such as high resolution T1- weighted, T2- weighted and Diffusion Tensor Imaging (DTI) and functional MRI (fMRI) [2]. These methods give information about morphological modifications in the brain and atrophy characterizing the specific dementia type. In addition brain perfusion and diffusion pattern and assessment of the changing un the resting state functional connectivity network of the brain can be studied with MRI. PET with different tracer molecules allow diagnosis of metabolism pattern in the brain (18F-FDG-PET), modifications in the neurotransmitter system and detection of brain plaques associated with dementia such as amyloid β or Tau aggregates . Data acquired from both modalities allow the reliable and differential diagnosis, prediction of pre-dementia stages, monitoring therapy response and additional research information regarding the mechanism of the condition.
Detailed description
Simultaneous measurements of PET and MR together as is recently became possible have allow spatial and temporal correlation between the two modalities opening a window of opportunities that was not available so far. The first practical advantage is because most neurological patients should go through both MRI and PET scans. Allowing both scans in the occasion significantly increase patient comfort. Furthermore, the simultaneous scans in contrast to sequential scans allow correlation between PET and MR informaiton without the concern of pathological brain modifications between the scans. Currently PET is performed combined with CT, which is superior to MR in the field of brain images. MR high soft tissue resolution as well as extra information it may provide regarding brain perfusion, diffusion, metabolic parameters etc., make the MR a far better modality for brain imaging than CT. In addition, the combined tool allow leveraging MR data to improve PET data quantification. PET issues such as motion correction, partial volume effect and correct localization of the tracer in the brain anatomy that cause PET image degradation and lower accuracy and robustness of PET quantitative parameters, can be solved by integrating MR data into the analysis. Several recently published articles have demonstrated different correction approaches for motion correction and partial volume effect showing an improvement in the PET images both visually and quantitatively . PET attenuation correction using MR data have also been studied, however this matter still need to be resolved. PET/MR for neurological conditions, in general, and specifically for conditions resulting in dementia, is a promising application with a large variety of research opportunities and its abilities need to be explored. Optimization of the acquisition protocols and even more so, the analysis and quantification protocols still need to be performed and will be the focus of this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dementia Patients | Experimental | Diagnostic Test: PET/MR |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients over the age of 18 with diagnosed conditions that might result in dementia or with diagnosed dementia in different stages.
Key exclusion criteria (3 listed)
- Patients younger than 18 years
- pregnancy
- contraindication to MRI or to intravenous gadolinium injection.
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 |
|---|---|---|
| PET/MRThe PET will be performed with one of the following tracers: 18F-FDG, 18F-DOPA or 18F-flutemetamol (Vizamyl). Proper tracer will be determined by the physician according to the condition. Patients that will agree, will be asked to perform two scans each with different tracer. The 3 tesla magnet of the MRI should allow acquisition of several contrasts within a reasonable time frame. The protocol will include T1 and T2-weighted images, perfusion and diffusion images. Images will be analyzed visually and quantitatively. Quantitative analysis will include MR parameters such as DWI apparent diffusion coefficient (ADC) and PET quantitative metabolic data such as standard uptake values (SUV), metabolic tumor volume (MTV), and total lesion glycolysis (TLG). Hidden image parameters will also be extracted for texture analysis purposes. Quantitative data will be correlated to clinical and pathological data to check accuracy, specificity and sensitivity. | Diagnostic test | Dementia Patients |
Primary outcome
Patients who preformed PET/MR for dementia applications
Time frame: 1 year
Optimization of brain acquisition protocols and reconstruction (with focus on attenuation correction algorithm) for patients with conditions causing dementia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MR in people with Dementia, run by Tel-Aviv Sourasky Medical Center.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Patients who preformed PET/MR for dementia applications (time frame: 1 year). 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 6 Nov 2019.