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Completed

NCT Number: NCT02287636

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

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.

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Key information

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fludeoxyglucose F 18

Radiation

Undergo fludeoxyglucose F 18 PET/CT

Other names: 18FDG, FDG

Positron Emission Tomography

Procedure

Undergo fludeoxyglucose F 18 PET/CT

Other names: FDG-PET, PET, PET scan, tomography, emission computed

Computed Tomography

Procedure

Undergo fludeoxyglucose F 18 PET/CT

Other names: tomography, computed

Magnetic Resonance Imaging

Procedure

Undergo PET/MRI

Other names: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Primary outcomes

  1. Diagnostic Accuracy of PET/MRI

    Time frame: 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.

  2. Diagnostic Accuracy of PET/CT

    Time frame: 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 outcomes

  1. SUVs Using PET/MRI

    Time frame: 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.

  2. SUVs Using PET/CT

    Time frame: 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.

  3. Radiation Dose Reduction Associated With PET/MRI

    Time frame: 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.

  4. Time Effort Associated With the PET/MRI

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2014
Registry last updated
Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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