Positron Emission Tomography/Magnetic Resonance Imaging in Patients

Lung Cancer Clinical Trial

Official title:

Evaluating Attenuation Correction Methods Applied to PET/MRI

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01557881
• Other study ID #: CASE15Z11
• Secondary ID: NCI-2012-00169
• Status: Terminated
• Phase: N/A
• Start date: February 2012
• Est. completion date: April 2015

Study information

• Verified date: February 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 98
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Lymphoma
• Malignant Neoplasm
• Melanoma
• Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	After PET/MRI
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.	After PET/MRI
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.	After PET/MRI