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Applying PET/MR for Dementia Applications

NCT04154254 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-11-06

No results posted yet for this study

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. 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.

Conditions

Interventions

DIAGNOSTIC_TEST

PET/MR

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.

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-10
Primary Completion
2021-03-10
Completion
2022-01-10

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04154254 on ClinicalTrials.gov