Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Cleveland, Ohio 44106


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

CASE1Z13


NCT ID:

NCT02287636


Secondary ID:

NCI-2014-00828


Study Acronym:


Brief Title:

PET/MRI and PET/CT in Diagnosing Younger Patients With Cancer


Official Title:

Clinical Evaluation of PET-MRI Versus PET-CT in Pediatric Oncology Patients


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

17 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Case Comprehensive Cancer Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Intervent


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Actual


Overall Contact Information

Official Name:Barbara Bangert
Principal Investigator
Case Comprehensive Cancer Center

Study Dates

Start Date:April 2013
Completion Date:April 2016
Completion Type:Actual
Primary Completion Date:April 2016
Primary Completion Type:Actual
Verification Date:April 2016
Last Changed Date:April 26, 2016
First Received Date:April 17, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Diagnostic accuracy of PET/MRI
Time Frame:1 day
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Diagnostic accuracy of PET/CT
Time Frame:1 day
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:SUVs using PET/MRI
Time Frame:1 day
Safety Issues:False
Description: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 Type:Secondary Outcome
Measure:SUVs using PET/CT
Time Frame:1 day
Safety Issues:False
Description: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 Type:Secondary Outcome
Measure:Radiation dose reduction associated with PET/MRI
Time Frame:1 day
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Time effort associated with the PET/MRI
Time Frame:1 day
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Radiation
Name:fludeoxyglucose F 18
Description:Undergo fludeoxyglucose F 18 PET/CT
Arm Name:Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MR
Other Name:18FDG
Intervention Type:Procedure
Name:positron emission tomography
Description:Undergo fludeoxyglucose F 18 PET/CT
Arm Name:Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MR
Other Name:FDG-PET
Intervention Type:Procedure
Name:computed tomography
Description:Undergo fludeoxyglucose F 18 PET/CT
Arm Name:Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MR
Other Name:tomography, computed
Intervention Type:Procedure
Name:positron emission tomography
Description:Undergo PET/MRI
Arm Name:Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MR
Other Name:FDG-PET
Intervention Type:Procedure
Name:magnetic resonance imaging
Description:Undergo PET/MRI
Arm Name:Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MR
Other Name:MRI

Study Arms

Study Arm Type:Experimental
Arm Name:Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI)
Description:Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Case Comprehensive Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.