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

PET-MRI: Evaluation, Optimization and Clinical Implementation

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.

Study Overview

• Status: Completed
• Conditions: Vasculitis; Dementia; Fever of Unknown Origin; Cardiac Disease; Osteomyelitis; Inflammatory Disease; FDG Avid Cancers
• Intervention / Treatment: Device: positron emission tomography; Device: computed tomography; Device: magnetic resonance imaging

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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; FDG-PET; PET scan; tomography, emission computed; Device: computed tomography; Undergo CT; Other Names: CT; tomography, computed; Device: magnetic resonance imaging; Undergo MRI; Other Names: MRI; NMRI; nuclear magnetic resonance imaging; NMR imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Image Quality Scores	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.	Day 1
Lesion Based Standard Uptake Values (SUV)	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.	Day 1
Area Under the Receiver Operating Characteristic Curve	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.	Day 1
Time Effort Associated With the PET-MRI Versus PET-CT With MRI	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.	Day 1
Radiation Dose Reduction With PET-MRI	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	Day 1

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Pablo Ros, MD, MPH, PhD, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2013
• Primary Completion (Actual): September 14, 2016
• Study Completion (Actual): October 2, 2018

Study Registration Dates

• First Submitted: March 7, 2014
• First Submitted That Met QC Criteria: March 7, 2014
• First Posted (Estimate): March 11, 2014

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Infections; Musculoskeletal Diseases; Bone Diseases; Body Temperature Changes; Bone Diseases, Infectious; Fever; Heart Diseases; Vasculitis; Fever of Unknown Origin; Osteomyelitis
• Other Study ID Numbers: CASE16Z12 (Other Identifier: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract); NCI-2014-00376 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No