Positron Emission Tomography/Magnetic Resonance Imaging in Patients

NCT ID: NCT01557881

Last Updated: 2020-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2015-04-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (PET/MRI)

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

Group Type: EXPERIMENTAL

magnetic resonance imaging with positron emission tomography scanning

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

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

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

• 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Faulhaber

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

NCI-2012-00169

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE15Z11

Identifier Type: -

Identifier Source: org_study_id