Clinical trial NCT01557881: Positron Emission Tomography/Magnetic Resonance Imaging in Patients
Official title: Evaluating Attenuation Correction Methods Applied to PET/MRI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colon Cancer
Head and Neck Cancer
Lung Cancer
Lymphoma
Malignant Neoplasm
Melanoma
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-03-20
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI
timeFrame: After PET/MRI
measure: Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
timeFrame: After PET/MRI
measure: Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
timeFrame: After PET/MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Peter Faulhaber
role: PRINCIPAL_INVESTIGATOR
References: