Colon Cancer, Head and Neck Cancer, Lung Cancer, Lymphoma, Malignant Neoplasm, Melanoma, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Conditions
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.
Interventions
DEVICEmagnetic resonance imaging with positron emission tomography scanning
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.
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI | After PET/MRI | 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. |
| Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc. | After PET/MRI | A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test. |
| Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc. | After PET/MRI | A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (PET/MRI) After undergoing standard PET/CT, patients undergo PET/MRI.
magnetic resonance imaging with positron emission tomography scanning: 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. | 98 |
| Total | 98 |
Baseline characteristics
| Characteristic | Diagnostic (PET/MRI) |
|---|---|
| Age, Customized 20-29 years | 2 Participants |
| Age, Customized 30-39 years | 6 Participants |
| Age, Customized 40-49 years | 16 Participants |
| Age, Customized 50-59 years | 26 Participants |
| Age, Customized 60-69 years | 20 Participants |
| Age, Customized 70-79 years | 20 Participants |
| Age, Customized 80-89 years | 7 Participants |
| Age, Customized 90-99 | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 81 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 81 Participants |
| Region of Enrollment United States | 98 participants |
| Sex/Gender, Customized Gender Female | 47 Participants |
| Sex/Gender, Customized Gender Male | 49 Participants |
| Sex/Gender, Customized Gender Unknown | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 98 |
| serious Total, serious adverse events | 0 / 98 |
Outcome results
Primary
Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.
Time frame: After PET/MRI
Population: Not available because data not collected.
Primary
Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.
Time frame: After PET/MRI
Population: Not available because data not collected.
Primary
Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI
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.
Time frame: After PET/MRI
Population: Not available because SUV data not collected.