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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-07

Study Completion Date

2018-10-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Disease Dementia Inflammatory Disease Fever of Unknown Origin Vasculitis Osteomyelitis FDG Avid Cancers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET-CT and PET-MRI

Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.

Group Type EXPERIMENTAL

positron emission tomography

Intervention Type DEVICE

Undergo PET

computed tomography

Intervention Type DEVICE

Undergo CT

magnetic resonance imaging

Intervention Type DEVICE

Undergo MRI

Interventions

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positron emission tomography

Undergo PET

Intervention Type DEVICE

computed tomography

Undergo CT

Intervention Type DEVICE

magnetic resonance imaging

Undergo MRI

Intervention Type DEVICE

Other Intervention Names

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FDG-PET PET PET scan tomography, emission computed tomography, computed CT MRI NMR imaging NMRI nuclear magnetic resonance imaging

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No