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

Case Comprehensive Cancer Center (Case CCC)

Status

Completed

Conditions

Fever of Unknown Origin

FDG Avid Cancers

Cardiac Disease

Osteomyelitis

Vasculitis

Inflammatory Disease

Dementia

Treatments

Device: positron emission tomography

Device: magnetic resonance imaging

Device: computed tomography

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02084147

P30CA043703 (U.S. NIH Grant/Contract)

NCI-2014-00376 (Registry Identifier)

CASE16Z12 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)