Cardiac Disease, Dementia, FDG Avid Cancers, Fever of Unknown Origin, Inflammatory Disease, Osteomyelitis, Vasculitis
Conditions
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.
Interventions
DEVICEpositron emission tomography
Undergo PET
DEVICEcomputed tomography
Undergo CT
DEVICEmagnetic resonance imaging
Undergo MRI
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Image Quality Scores | 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. |
| Lesion Based Standard Uptake Values (SUV) | 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. |
| Area Under the Receiver Operating Characteristic Curve | 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. |
| Time Effort Associated With the PET-MRI Versus PET-CT With MRI | 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. |
| Radiation Dose Reduction With PET-MRI | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PET-CT and PET-MRI Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.
positron emission tomography: Undergo PET
computed tomography: Undergo CT
magnetic resonance imaging: Undergo MRI | 72 |
| Total | 72 |
Baseline characteristics
| Characteristic | PET-CT and PET-MRI |
|---|---|
| Age, Customized 10-19 years | 4 Participants |
| Age, Customized 20-29 years | 1 Participants |
| Age, Customized 30-39 years | 3 Participants |
| Age, Customized 40-49 years | 4 Participants |
| Age, Customized 50-59 years | 25 Participants |
| Age, Customized 60-69 years | 17 Participants |
| Age, Customized 70-79 years | 14 Participants |
| Age, Customized 80-89 years | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 41 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Region of Enrollment United States | 72 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 72 |
| serious Total, serious adverse events | 0 / 72 |
Outcome results
Primary
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 frame: Day 1
Population: No data was obtained from this study group as the patient cohort was inconsistent
Primary
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.
Time frame: Day 1
Population: No data was obtained from this study group as the patient cohort was inconsistent
Primary
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.
Time frame: Day 1
Population: No data was obtained from this study group as the patient cohort was inconsistent
Primary
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
Time frame: Day 1
Population: No data was obtained from this study group as the patient cohort was inconsistent
Primary
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.
Time frame: Day 1
Population: No data was obtained from this study group as the patient cohort was inconsistent