Clinical trial NCT02287636: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-11-11
Enrollment: 13
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Diagnostic Accuracy of PET/MRI
timeFrame: 1 day
measure: Diagnostic Accuracy of PET/CT
timeFrame: 1 day
Secondary outcomes:
measure: SUVs Using PET/MRI
timeFrame: 1 day
measure: SUVs Using PET/CT
timeFrame: 1 day
measure: Radiation Dose Reduction Associated With PET/MRI
timeFrame: 1 day
measure: Time Effort Associated With the PET/MRI
timeFrame: 1 day
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Barbara Bangert
role: PRINCIPAL_INVESTIGATOR
References: