PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases
PET-MRI: Evaluation, Optimization and Clinical Implementation
3 other identifiers
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 7, 2013
CompletedFirst Submitted
Initial submission to the registry
March 7, 2014
CompletedFirst Posted
Study publicly available on registry
March 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2018
CompletedResults Posted
Study results publicly available
October 29, 2019
CompletedOctober 29, 2019
October 1, 2019
3.5 years
March 7, 2014
October 11, 2019
October 11, 2019
Conditions
Outcome Measures
Primary Outcomes (5)
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
Study Arms (1)
PET-CT and PET-MRI
EXPERIMENTALPatients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.
Interventions
Undergo PET
Undergo MRI
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
- Individuals who are not willing or capable of giving informed consent or assent (with legal guardian consent)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Case Comprehensive Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
No data was obtained from this study group as the patient cohort was inconsistent
Results Point of Contact
- Title
- Philipp Frank Graner
- Organization
- Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Pablo Ros, MD, MPH, PhD
Case Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2014
First Posted
March 11, 2014
Study Start
March 7, 2013
Primary Completion
September 14, 2016
Study Completion
October 2, 2018
Last Updated
October 29, 2019
Results First Posted
October 29, 2019
Record last verified: 2019-10