N/A
N=72
PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases
Cardiac Disease · Dementia · Inflammatory Disease · Fever of Unknown Origin · Vasculitis
Bottom Line
View on ClinicalTrials.gov: NCT02084147 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Overall Image Quality Scores
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- positron emission tomography (Device); computed tomography (Device); magnetic resonance imaging (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Image Quality Scores |
— | — |
| PRIMARY Lesion Based Standard Uptake Values (SUV) |
— | — |
| PRIMARY Area Under the Receiver Operating Characteristic Curve |
— | — |
| PRIMARY Time Effort Associated With the PET-MRI Versus PET-CT With MRI |
— | — |
| PRIMARY Radiation Dose Reduction With PET-MRI |
— | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02084147). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.