Text Size

Positron Emission Tomography/Magnetic Resonance Imaging in Patients

This study is currently recruiting participants.
Verified April 2013 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01557881
First received: March 16, 2012
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluating Attenuation Correction Methods Applied to PET/MRI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Standardized uptake value (SUV) on PET/CT compared to PET/MRI [ Time Frame: After PET/MRI ] [ Designated as safety issue: No ]
    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. [ Time Frame: After PET/MRI ] [ Designated as safety issue: No ]
    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. [ Time Frame: After PET/MRI ] [ Designated as safety issue: No ]
    A Likert five point scale will be used. Quality scores will be compared using a Wilcoxon signed rank test.


Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557881

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Peter Faulhaber     216-844-3107     peter.faulhaber@uhhospitals.org    
Principal Investigator: Peter Faulhaber            
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Peter Faulhaber Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01557881     History of Changes
Other Study ID Numbers: CASE15Z11, NCI-2012-00169
Study First Received: March 16, 2012
Last Updated: April 23, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Neoplasms
Colonic Neoplasms
Head and Neck Neoplasms
Lung Neoplasms
Lymphoma
Melanoma
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 16, 2013