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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02084147
Recruitment Status : Suspended (Interim Analysis)
First Posted : March 11, 2014
Last Update Posted : October 31, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Cardiac Disease Dementia Inflammatory Disease Fever of Unknown Origin Vasculitis Osteomyelitis FDG Avid Cancers Device: positron emission tomography Device: computed tomography Device: magnetic resonance imaging Not Applicable

Detailed Description:


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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 530 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET-MRI: Evaluation, Optimization and Clinical Implementation
Actual Study Start Date : March 7, 2013
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PET-CT and PET-MRI
Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.
Device: positron emission tomography
Undergo PET
Other Names:
  • PET
  • PET scan
  • tomography, emission computed
Device: computed tomography
Undergo CT
Other Names:
  • tomography, computed
  • CT
Device: magnetic resonance imaging
Undergo MRI
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

Primary Outcome Measures :
  1. Overall image quality scores [ Time Frame: Day 1 ]
    Overall image quality scores obtained from the two imaging modalities will be compared with the hypothesis that hybrid PET-MRI images is as good as PET-CT images or superior (not inferior) to the PET-CT images. Evaluation of overall image quality will be assessed using the following criteria: 1=excellent, 2=good, 3=acceptable, 4=poor, 5=not acceptable. A Wilcoxon (Mann-Whitney) rank-sum test with a 0.100 significance level will be used.

  2. Lesion based standard uptake values (SUV) [ Time Frame: Day 1 ]
    Lesion based SUV will be estimated and compared for PET-MR and PET-CT images in normal organs and compared. A two-sided two-sample t-test will be used to show significance of difference.

  3. Area under the receiver operating characteristic curve [ Time Frame: Day 1 ]
    A two-sided z-test will be used to detect the difference in the area under the curve showing the sensitivity, specificity, positive and negative predictive values as well as accuracy of diagnostic information.

  4. Time effort associated with the PET-MRI versus PET-CT with MRI [ Time Frame: Day 1 ]
    Statistical difference in time between PET-MRI versus sequential approach for PET-CT plus MRI. Workflow with shortest timely efforts and sufficient diagnostic information will be established as routine procedure.

  5. Radiation dose reduction with PET-MRI [ Time Frame: Day 1 ]
    Dose measurements will be used to calculate effective radiation dose in each patient. Dose calculations of effective dose will be used to estimate dose savings in omitting the CT component of PET-CT. Statistical tests will use a 0.10 significance level and will be 2-sided

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02084147

United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Pablo Ros, MD, MPH, PhD Case Comprehensive Cancer Center

Responsible Party: Case Comprehensive Cancer Center Identifier: NCT02084147     History of Changes
Other Study ID Numbers: CASE16Z12
NCI-2014-00376 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE16Z12 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Heart Diseases
Fever of Unknown Origin
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Vascular Diseases
Cardiovascular Diseases
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Body Temperature Changes
Signs and Symptoms