PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases



Status:Suspended
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology, Neurology, Orthopedic
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:11/2/2017
Start Date:March 7, 2013
End Date:October 2018

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PET-MRI: Evaluation, Optimization and Clinical Implementation

This randomized pilot clinical trial studies how well positron emission tomography
(PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed
tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases.
PET-MRI combines two imaging methods that can be used to evaluate disease. PET-MRI is similar
to standard-of-care PET-CT, but exposes the patient to less radiation. It is not yet known
whether PET-MRI produces better image quality than PET-CT in diagnosing patients with cancer,
cardiac disease, or neurologic disease.

PRIMARY OBJECTIVES:

I. To assess and optimize image quality of PET and MRI focusing on technical artifacts and
their correction.

II. To assess the accuracy of PET quantification based on MR attenuation correction (MRAC)
derived from various MRI sequences and reconstruction algorithms including the effect of
routinely used Gadolinium-based contrast agents on MRAC.

III. To determine the clinical and diagnostic accuracy of PET-MRI in comparison to
standard-of-care diagnostic imaging.

IV. To assess the efficacy and workflow in combining PET and MRI in one single examination as
compared to separate imaging studies.

V. To assess the potential for radiation dose reduction if PET-CT is substituted by PET-MRI,
thus avoiding the radiation exposure from the CT-component.

Inclusion Criteria:

- Clinically indicated PET/PET-CT (with or without clinically indicated diagnostic MRI)

- Presenting with one of the four conditions specified below

- Fludeoxyglucose F 18 (FDG) avid cancers

- Cardiac disease (cardiac viability assessment)

- Neurologic disorders (dementia)

- Inflammatory disease (for example fever of unknown origin, vasculitis,
osteomyelitis)

Exclusion Criteria:

- Pregnancy and lactation

- Contraindications to undergo MRI

- Cardiac pacemaker and metal devices (as specified in a separate MRI Informed consent)

- Claustrophobia or inability to tolerate MRI examination (lay still for approximately 1
hour and hold breath intermittently)

- Previously known allergies against MRI contrast agents (exclusion criterion only for
contrast enhanced MRI)

- Renal insufficiency: glomerular filtration rate (GFR) < 40ml/min/1.73m^2 and following
European Society of Urogenital Radiology (ESUR) guidelines (exclusion criterion only
for contrast enhanced MRI)

- Individuals who are not willing or capable of giving informed consent or assent (with
legal guardian consent)
We found this trial at
1
site
11100 Euclid Avenue
Cleveland, Ohio 44106
216.844.8797
Principal Investigator: Pablo Ros, MD, MPH, PhD
Phone: 216-983-4829
Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
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mi
from
Cleveland, OH
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