Evaluating Attenuation Correction Methods Applied to PET/MRI
N/A
N/A
Both
Colon Cancer, Head and Neck Cancer, Lung Cancer, Lymphoma, Malignant Neoplasm, Melanoma, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Trial Information
Evaluating Attenuation Correction Methods Applied to PET/MRI
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Standardized uptake value (SUV) on PET/CT compared to PET/MRI
Outcome 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.
Outcome Time Frame:
After PET/MRI
Safety Issue:
No
Principal Investigator
Peter Faulhaber
Investigator Role:
Principal Investigator
Investigator Affiliation:
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CASE15Z11
NCT ID:
NCT01557881
Start Date:
February 2012
Completion Date:
Related Keywords:
- Colon Cancer
- Head and Neck Cancer
- Lung Cancer
- Lymphoma
- Malignant Neoplasm
- Melanoma
- Unspecified Adult Solid Tumor, Protocol Specific
- Unspecified Childhood Solid Tumor, Protocol Specific
- Neoplasms
- Colonic Neoplasms
- Head and Neck Neoplasms
- Lung Neoplasms
- Lymphoma
- Melanoma
Name | Location |
|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
