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

Childhood Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287636
• Other study ID #: CASE1Z13
• Secondary ID: NCI-2014-00828CA
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: February 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Cancer

Intervention

Radiation:
• fludeoxyglucose F 18
Undergo fludeoxyglucose F 18 PET/CT

Procedure:
• 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

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 day
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.	1 day
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.	1 day
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.	1 day
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.	1 day
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.	1 day