Clinical trial NCT02084147: PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases
Official title: PET-MRI: Evaluation, Optimization and Clinical Implementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Dementia
Inflammatory Disease
Fever of Unknown Origin
Vasculitis
Osteomyelitis
FDG Avid Cancers
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-03-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

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)

Primary outcomes:
measure: Overall Image Quality Scores
timeFrame: Day 1
measure: Lesion Based Standard Uptake Values (SUV)
timeFrame: Day 1
measure: Area Under the Receiver Operating Characteristic Curve
timeFrame: Day 1
measure: Time Effort Associated With the PET-MRI Versus PET-CT With MRI
timeFrame: Day 1
measure: Radiation Dose Reduction With PET-MRI
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Pablo Ros, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: