Trial Outcomes & Findings for PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases (NCT NCT02084147)
NCT ID: NCT02084147
Last Updated: 2019-10-29
Results Overview
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.
COMPLETED
NA
72 participants
Day 1
2019-10-29
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases
Baseline characteristics by cohort
| Measure |
PET-CT and PET-MRI
n=72 Participants
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
|
|---|---|
|
Age, Customized
10-19 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
20-29 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
3 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
25 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
17 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
14 Participants
n=5 Participants
|
|
Age, Customized
80-89 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: No data was obtained from this study group as the patient cohort was inconsistent
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1Population: No data was obtained from this study group as the patient cohort was inconsistent
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1Population: No data was obtained from this study group as the patient cohort was inconsistent
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1Population: No data was obtained from this study group as the patient cohort was inconsistent
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1Population: No data was obtained from this study group as the patient cohort was inconsistent
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
Outcome measures
Outcome data not reported
Adverse Events
PET-CT and PET-MRI
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Philipp Frank Graner
Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place