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Completed

NCT Number: NCT02084147

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

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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Key information

Conditions

Cardiac Disease Body Temperature Changes Bone Diseases Bone Diseases, Infectious Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Dementia FDG Avid Cancers Fever Fever of Unknown Origin Heart Diseases Infections Inflammatory Disease Mental Disorders Musculoskeletal Diseases Nervous System Diseases Neurocognitive Disorders Osteomyelitis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Positron emission tomography

Device

Undergo PET

Other names: FDG-PET, PET, PET scan, tomography, emission computed

computed tomography

Device

Undergo CT

Other names: tomography, computed, CT

Magnetic Resonance Imaging

Device

Undergo MRI

Other names: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

PET-MRI: Evaluation, Optimization and Clinical Implementation

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Mar 11, 2014
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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