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Positron Emission Tomography/Magnetic Resonance Imaging in Patients

Primary Purpose

Colon Cancer, Head and Neck Cancer, Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
magnetic resonance imaging with positron emission tomography scanning
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (PET/MRI)

Arm Description

After undergoing standard PET/CT, patients undergo PET/MRI.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2012
Last Updated
February 7, 2020
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01557881
Brief Title
Positron Emission Tomography/Magnetic Resonance Imaging in Patients
Official Title
Evaluating Attenuation Correction Methods Applied to PET/MRI
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Funding unavailable
Study Start Date
February 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Head and Neck Cancer, Lung Cancer, Lymphoma, Malignant Neoplasm, Melanoma, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (PET/MRI)
Arm Type
Experimental
Arm Description
After undergoing standard PET/CT, patients undergo PET/MRI.
Intervention Type
Device
Intervention Name(s)
magnetic resonance imaging with positron emission tomography scanning
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed, MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging, Philips Ingenuity TF PET/MR
Intervention Description
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.
Primary Outcome Measure Information:
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
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
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Faulhaber
Organizational Affiliation
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Positron Emission Tomography/Magnetic Resonance Imaging in Patients

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