Positron Emission Tomography/Magnetic Resonance Imaging in Patients

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01557881
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 98
• Location: 1
• Arm: 1
• Duration (Months): 37.9
• Patients Per Site Per Month: 2.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer; Head and Neck Cancer; Lung Cancer; Lymphoma; Malignant Neoplasm; Melanoma; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific	Device: magnetic resonance imaging with positron emission tomography scanning	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 98 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluating Attenuation Correction Methods Applied to PET/MRI
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Diagnostic (PET/MRI) After undergoing standard PET/CT, patients undergo PET/MRI.

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.; Other Names: FDG-PET PET PET scan tomography, emission computed MRI NMR imaging NMRI nuclear magnetic resonance imaging Philips Ingenuity TF PET/MR

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• Case Comprehensive Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Peter Faulhaber, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT01557881
• Other Study ID Numbers: CASE15Z11; NCI-2012-00169
• First Posted: Mar 20, 2012
• Last Update Posted: Feb 24, 2020
• Last Verified: Feb 1, 2020

• Additional relevant MeSH terms: Neoplasms; Head and Neck Neoplasms

Study Results

Participant Flow

Arm/Group Title	Diagnostic (PET/MRI)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	98
COMPLETED	98
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Diagnostic (PET/MRI)
Arm/Group Description	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.
Overall Participants	98
Age, Customized (Count of Participants)
20-29 years	2 2%
30-39 years	6 6.1%
40-49 years	16 16.3%
50-59 years	26 26.5%
60-69 years	20 20.4%
70-79 years	20 20.4%
80-89 years	7 7.1%
90-99	1 1%
Sex/Gender, Customized (Count of Participants)
Female	47 48%
Male	49 50%
Unknown	2 2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 2%
Not Hispanic or Latino	81 82.7%
Unknown or Not Reported	15 15.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	12 12.2%
White	81 82.7%
More than one race	2 2%
Unknown or Not Reported	2 2%
Region of Enrollment (participants) [Number]
United States	98 100%

Outcome Measures

1. Primary Outcome

Title	Standardized Uptake Value (SUV) on PET/CT Compared to PET/MRI
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.
Time Frame	After PET/MRI

Outcome Measure Data

Analysis Population Description

Not available because SUV data not collected.

Arm/Group Title	Diagnostic (PET/MRI)
Arm/Group Description	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.
Measure Participants	0

2. Primary Outcome

Title	Individual Quality Scores, Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
Description	A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.
Time Frame	After PET/MRI

Outcome Measure Data

Analysis Population Description

Not available because data not collected.

Arm/Group Title	Diagnostic (PET/MRI)
Arm/Group Description	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.
Measure Participants	0

3. Primary Outcome

Title	Comparison of Quality Scores (PET/CT vs PET/MRI), Comprised of Various Qualities of the Image and Include Contrast, Brightness, Resolution, Etc.
Description	A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.
Time Frame	After PET/MRI

Outcome Measure Data

Analysis Population Description

Not available because data not collected.

Arm/Group Title	Diagnostic (PET/MRI)
Arm/Group Description	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.
Measure Participants	0

Adverse Events

Time Frame	At time of scan. No more than 24 hours.
Adverse Event Reporting Description	No adverse events were documented for this study
Arm/Group Title	Diagnostic (PET/MRI)
Arm/Group Description	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.
All Cause Mortality
	Diagnostic (PET/MRI)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Diagnostic (PET/MRI)
	Affected / at Risk (%)	# Events
Total	0/98 (0%)
Other (Not Including Serious) Adverse Events
	Diagnostic (PET/MRI)
	Affected / at Risk (%)	# Events
Total	0/98 (0%)

Limitations/Caveats

Outcome data not collected.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.