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NCT01557881 · REGISTRY CONDITION SEARCH

Positron Emission Tomography/Magnetic Resonance Imaging in Patients

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
TERMINATED
Registry last update
2020-02-24

This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging (MRI) in patients undergoing PET/computed tomography (CT). Diagnostic procedures, such as PET/MRI, may help doctors diagnose cancer or help doctors predict a patient's response to treatment

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI

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outcome · POSTED

Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.

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outcome · POSTED

Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Only patients who are referred by their physician to have a clinical PET/CT will be eligible to participate in the study * we propose to obtain a second PET/MRI on 100 patients after their clinical PET/CT imaging that spans several disease categories and includes the following cancers: lung, colon, melanoma, head/neck and lymphoma * In addition to oncology patients, we anticipate imaging a subset of non-cancer patients who will also be imaged subsequent to their clinical PET/CT who will be referrals from neurology and cardiology * All subjects will be at least 18 years old, or if under 18, parents or guardians must give consent * Subjects must be stable and have experienced no adverse events from previous clinical PET/CT examination Exclusion Criteria: * Subjects who do not meet the above inclusion criteria * Subjects unwilling or unable to sign the informed consent form * Subjects who are cognitively impaired and thus unable to give informed consent * Subjects unable to undergo MRI scanning due to exclusion via University Hospital Case Medical Center (UHCMC) MRI restrictions (e.g. implanted metallic or electronic devices, hip or other joint replacements, history of kidney disease, unacceptable creatinine or glomerular filtration rate \[GFR\], etc) * Patients who are pregnant
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    After undergoing standard PET/CT, patients undergo PET/MRI.
    intervention Names
    1. Device: magnetic resonance imaging with positron emission tomography scanning
    label
    Diagnostic (PET/MRI)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Diagnostic (PET/MRI)
    description
    University Hospitals Seidman Cancer Center \[SCC\] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status.
    name
    magnetic resonance imaging with positron emission tomography scanning
    other Names
    1. FDG-PET
    2. PET
    3. PET scan
    4. tomography, emission computed
    5. MRI
    6. NMR imaging
    7. NMRI
    8. nuclear magnetic resonance imaging
    9. Philips Ingenuity TF PET/MR
    type
    DEVICE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
DIAGNOSTIC
Enrollment
count
98
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    SUVs for various normal tissues such as liver, cardiac blood pool, and bone will be used. Selected lesions will be assessed as well. Maximum and mean SUVs will be measured for each imaging device. The SUVs and tumor/background ratios will be measured.
    measure
    Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI
    time Frame
    After PET/MRI
  2. description
    A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.
    measure
    Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
    time Frame
    After PET/MRI
  3. description
    A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.
    measure
    Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
    time Frame
    After PET/MRI
Full study description
brief Summary
This clinical trial studies positron emission tomography (PET)/magnetic resonance imaging (MRI) in patients undergoing PET/computed tomography (CT). Diagnostic procedures, such as PET/MRI, may help doctors diagnose cancer or help doctors predict a patient's response to treatment
detailed Description
PRIMARY OBJECTIVES: I. To acquire PET/MRI scans of 100 patients which will be compared with PET/CT scans of the same subjects. The PET/CT scans will be used to provide the gold standard for evaluating the image quality and quantitative performance of the PET/MRI scans. After comparison and evaluation of the imaging capabilities and performance of the sequential PET/MRI imaging system for these 100 subjects, a second cohort of hundred consecutive subjects may be necessary and again comparisons made to the current standard of PET imaging, PET/CT. This validation of the attenuation correction methods and quantitative accuracy of the PET/MRI device compared to PET/CT will be a continuous iterative process that will result in optimized performance of the PET/MRI and will be a key step in its becoming available to other clinical research projects both within the Seidman Cancer Center as well as in other institutions. OUTLINE: After undergoing standard PET/CT, patients undergo PET/MRI.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice