Trial Outcomes & Findings for PET/MRI and PET/CT in Diagnosing Younger Patients With Cancer (NCT NCT02287636)
NCT ID: NCT02287636
Last Updated: 2020-02-24
Results Overview
Evaluation of the PET/MR imaging platform will be based on the ability to detect lesions. Evaluation of each lesion will be recorded using the following 5 point rating scale: 1=benign, 2=probably benign, 3=indeterminate, 4=probably malignant, 5=malignant. A Wilcoxon (Mann-Whitney) rank-sum test and two-sided z-test will be used to compare diagnostic accuracy of PET/MRI with PET/CT.
COMPLETED
NA
13 participants
1 day
2020-02-24
Participant Flow
Participant milestones
| Measure |
Diagnostic (Fludeoxyglucose F 18 PET/CT and PET/MRI)
Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.
fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT
positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT
computed tomography: Undergo fludeoxyglucose F 18 PET/CT
positron emission tomography: Undergo PET/MRI
magnetic resonance imaging: Undergo PET/MRI
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PET/MRI and PET/CT in Diagnosing Younger Patients With Cancer
Baseline characteristics by cohort
| Measure |
Diagnostic (Fludeoxyglucose F 18 PET/CT and PET/MRI)
n=13 Participants
Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.
fludeoxyglucose F 18: Undergo fludeoxyglucose F 18 PET/CT
positron emission tomography: Undergo fludeoxyglucose F 18 PET/CT
computed tomography: Undergo fludeoxyglucose F 18 PET/CT
positron emission tomography: Undergo PET/MRI
magnetic resonance imaging: Undergo PET/MRI
|
|---|---|
|
Age, Customized
0-9 years
|
2 Participants
n=5 Participants
|
|
Age, Customized
10-19 years
|
11 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
7 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
5 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Unknown
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.
Evaluation of the PET/MR imaging platform will be based on the ability to detect lesions. Evaluation of each lesion will be recorded using the following 5 point rating scale: 1=benign, 2=probably benign, 3=indeterminate, 4=probably malignant, 5=malignant. A Wilcoxon (Mann-Whitney) rank-sum test and two-sided z-test will be used to compare diagnostic accuracy of PET/MRI with PET/CT.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 dayPopulation: Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.
Evaluation of the PET/CT imaging platform will be based on the ability to detect lesions. Evaluation of each lesion will be recorded using the following 5 point rating scale: 1=benign, 2=probably benign, 3=indeterminate, 4=probably malignant, 5=malignant. A Wilcoxon (Mann-Whitney) rank-sum test and two-sided z-test will be used to compare diagnostic accuracy of PET/CT with PET/MRI.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 dayPopulation: Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.
The means and standard deviations of SUVs will be obtained and compared between PET/MRI and PET/CT using a two-sided two-sample t-test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 dayPopulation: Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.
The means and standard deviations of SUVs will be obtained and compared between PET/MRI and PET/CT using a two-sided two-sample t-test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 dayPopulation: Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.
Tabulations of summary statistics, graphical presentations, and statistical analyses will be performed. Statistical tests will use a 0.10 significance level and will be 2-sided unless otherwise noted. Confidence intervals, both individual and simultaneous, will be at 90% confidence level unless stated otherwise.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 dayPopulation: Sincere efforts were made to gather and report the data, however, no data is available for the study as PI has left institution long ago and not accessible.
Tabulations of summary statistics, graphical presentations, and statistical analyses will be performed. Statistical tests will use a 0.10 significance level and will be 2-sided unless otherwise noted. Confidence intervals, both individual and simultaneous, will be at 90% confidence level unless stated otherwise.
Outcome measures
Outcome data not reported
Adverse Events
Diagnostic (Fludeoxyglucose F 18 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