Childhood Cancer
Conditions
Brief summary
This pilot clinical trial studies how well positron emission tomography (PET)/magnetic resonance imaging (MRI) works compared to PET/computed tomography (CT) in diagnosing younger patients with cancer. PET/MRI and PET/CT are procedures that combine the pictures from a PET scan and an MRI scan or a CT scan. The PET and MRI scans or PET and CT scans are done at the same time with the same machine. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. It is not yet known whether PET/MRI works better than PET/CT in diagnosing younger patients with cancer.
Detailed description
PRIMARY OBJECTIVES: I. Determine the diagnostic accuracy of PET/MRI as compared to the standard of reference PET/CT in lesion detection and lesion characterization. SECONDARY OBJECTIVES: I. Obtain quantitative measurements in various body regions of standardized uptake values (SUV) in normal tissue and foci of pathologic tracer uptake in PET/MRI of pediatric patients with oncologic disease using various magnetic resonance attenuation correction (MRAC) methods and compare those to respective SUV based on CT attenuation correction. II. Assess the potential for radiation dose reduction with PET/MRI when eliminating CT radiation dose. III. Assess time efforts and workflow improvement with PET/MRI compared to sequential PET/CT plus MRI. OUTLINE: Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.
Interventions
RADIATIONfludeoxyglucose F 18
Undergo fludeoxyglucose F 18 PET/CT
PROCEDUREpositron emission tomography
Undergo fludeoxyglucose F 18 PET/CT
PROCEDUREcomputed tomography
Undergo fludeoxyglucose F 18 PET/CT
PROCEDUREmagnetic resonance imaging
Undergo PET/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
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are referred by their physician for clinically indicated diagnostic fludeoxyglucose F 18 (18F-FDG) PET/CT (with or without clinically indicated diagnostic MRI) * Subjects with malignancies including hematologic disorders * Subjects NOT requiring sedation or anesthesia * Stable physical medical conditions (patients conscious and comfortable, scheduled for an elective diagnostic imaging)
Exclusion criteria
* Subjects who are unable or unwilling to give their assent to both examinations if \> 7 years old * Subjects requiring general anesthesia or sedation in order to undergo PET/CT or MRI * Subjects unable to undergo magnetic resonance (MR) scanning due to exclusion by University Hospitals-Case Medical Center restriction policies for Magnetic Resonance Imaging (UHCMC MRI restriction policies) as mentioned in the standard UHCMC MRI informed consent form * Previously known allergies against MRI contrast agents (exclusion criterion only for contrast enhanced MRI) * Pregnant or breast feeding subjects, as determined by standard questionnaire administered prior to scanning
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy of PET/MRI | 1 day | 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. |
| Diagnostic Accuracy of PET/CT | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SUVs Using PET/MRI | 1 day | 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. |
| SUVs Using PET/CT | 1 day | 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. |
| Radiation Dose Reduction Associated With PET/MRI | 1 day | 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. |
| Time Effort Associated With the PET/MRI | 1 day | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Diagnostic (Fludeoxyglucose F 18 PET/CT and PET/MRI) |
|---|---|
| Age, Customized 0-9 years | 2 Participants |
| Age, Customized 10-19 years | 11 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 13 participants |
| Sex/Gender, Customized Gender Female | 7 Participants |
| Sex/Gender, Customized Gender Male | 5 Participants |
| Sex/Gender, Customized Gender Unknown | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Diagnostic Accuracy of PET/CT
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.
Time frame: 1 day
Population: 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.
Primary
Diagnostic Accuracy of PET/MRI
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.
Time frame: 1 day
Population: 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.
Secondary
Radiation Dose Reduction Associated With PET/MRI
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.
Time frame: 1 day
Population: 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.
Secondary
SUVs Using PET/CT
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.
Time frame: 1 day
Population: 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.
Secondary
SUVs Using PET/MRI
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.
Time frame: 1 day
Population: 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.
Secondary
Time Effort Associated With the PET/MRI
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.
Time frame: 1 day
Population: 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.