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

Primary Purpose

Cardiac Disease, Dementia, Inflammatory Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
positron emission tomography
computed tomography
magnetic resonance imaging
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET-CT and PET-MRI

Arm Description

Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
March 7, 2014
Last Updated
October 11, 2019
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02084147
Brief Title
PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases
Official Title
PET-MRI: Evaluation, Optimization and Clinical Implementation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 7, 2013 (Actual)
Primary Completion Date
September 14, 2016 (Actual)
Study Completion Date
October 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease, Dementia, Inflammatory Disease, Fever of Unknown Origin, Vasculitis, Osteomyelitis, FDG Avid Cancers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PET-CT and PET-MRI
Arm Type
Experimental
Arm Description
Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.
Intervention Type
Device
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Undergo PET
Intervention Type
Device
Intervention Name(s)
computed tomography
Other Intervention Name(s)
tomography, computed, CT
Intervention Description
Undergo CT
Intervention Type
Device
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Undergo MRI
Primary Outcome Measure Information:
Title
Overall Image Quality Scores
Description
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.
Time Frame
Day 1
Title
Lesion Based Standard Uptake Values (SUV)
Description
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.
Time Frame
Day 1
Title
Area Under the Receiver Operating Characteristic Curve
Description
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.
Time Frame
Day 1
Title
Time Effort Associated With the PET-MRI Versus PET-CT With MRI
Description
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.
Time Frame
Day 1
Title
Radiation Dose Reduction With PET-MRI
Description
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
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Ros, MD, MPH, PhD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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

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