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

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

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 Overview

• Status: Completed
• Conditions: Childhood Cancer
• Intervention / Treatment: Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography; Procedure: computed tomography; Procedure: positron emission tomography; Procedure: magnetic resonance imaging

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (fludeoxyglucose F 18 PET/CT and PET/MRI); Patients undergo fludeoxyglucose F 18 PET/CT followed by PET/MRI.

Radiation: fludeoxyglucose F 18; Undergo fludeoxyglucose F 18 PET/CT; Other Names: 18FDG; FDG; Procedure: positron emission tomography; Undergo fludeoxyglucose F 18 PET/CT; Other Names: PET; FDG-PET; PET scan; tomography, emission computed; Procedure: computed tomography; Undergo fludeoxyglucose F 18 PET/CT; Other Names: tomography, computed; Procedure: positron emission tomography; Undergo PET/MRI; Other Names: PET; FDG-PET; PET scan; tomography, emission computed; Procedure: magnetic resonance imaging; Undergo PET/MRI; Other Names: MRI; NMRI; nuclear magnetic resonance imaging; NMR imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Barbara Bangert, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 17, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 11, 2014

Study Record Updates

• Last Update Posted (Actual): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 21, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: CASE1Z13; P30CA043703 (U.S. NIH Grant/Contract); NCI-2014-00828 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); CASE 1Z13 (Other Identifier: Case Comprehensive Cancer Center)