PET-MRI in Diagnosing Patients With Cancer, Cardiac Diseases, or Neurologic Diseases

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02084147
First received: March 7, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

This randomized pilot clinical trial studies how well positron emission tomography (PET)-magnetic resonance imaging (MRI) works compared to standard-of-care PET-computed tomography (CT) in diagnosing patients with cancer, cardiac diseases, or neurologic diseases. PET-MRI combines two imaging methods that can be used to evaluate disease. PET-MRI is similar to standard-of-care PET-CT, but exposes the patient to less radiation. It is not yet known whether PET-MRI produces better image quality than PET-CT in diagnosing patients with cancer, cardiac disease, or neurologic disease.


Condition Intervention
Cardiac Disease
Dementia
Inflammatory Disease
Fever of Unknown Origin
Vasculitis
Osteomyelitis
FDG Avid Cancers
Procedure: positron emission tomography
Procedure: computed tomography
Procedure: magnetic resonance imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PET-MRI: Evaluation, Optimization and Clinical Implementation

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall image quality scores [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Overall image quality scores obtained from the two imaging modalities will be compared with the hypothesis that hybrid PET-MRI images is as good as PET-CT images or superior (not inferior) to the PET-CT images. Evaluation of overall image quality will be assessed using the following criteria: 1=excellent, 2=good, 3=acceptable, 4=poor, 5=not acceptable. A Wilcoxon (Mann-Whitney) rank-sum test with a 0.100 significance level will be used.

  • Lesion based standard uptake values (SUV) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Lesion based SUV will be estimated and compared for PET-MR and PET-CT images in normal organs and compared. A two-sided two-sample t-test will be used to show significance of difference.

  • Area under the receiver operating characteristic curve [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    A two-sided z-test will be used to detect the difference in the area under the curve showing the sensitivity, specificity, positive and negative predictive values as well as accuracy of diagnostic information.

  • Time effort associated with the PET-MRI versus PET-CT with MRI [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Statistical difference in time between PET-MRI versus sequential approach for PET-CT plus MRI. Workflow with shortest timely efforts and sufficient diagnostic information will be established as routine procedure.

  • Radiation dose reduction with PET-MRI [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Dose measurements will be used to calculate effective radiation dose in each patient. Dose calculations of effective dose will be used to estimate dose savings in omitting the CT component of PET-CT. Statistical tests will use a 0.10 significance level and will be 2-sided


Estimated Enrollment: 530
Study Start Date: April 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET-CT and PET-MRI
Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.
Procedure: positron emission tomography
Undergo PET-CT
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo PET-CT
Other Name: tomography, computed
Procedure: magnetic resonance imaging
Undergo PET-MRI
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess and optimize image quality of PET and MRI focusing on technical artifacts and their correction.

II. To assess the accuracy of PET quantification based on MR attenuation correction (MRAC) derived from various MRI sequences and reconstruction algorithms including the effect of routinely used Gadolinium-based contrast agents on MRAC.

III. To determine the clinical and diagnostic accuracy of PET-MRI in comparison to standard-of-care diagnostic imaging.

IV. To assess the efficacy and workflow in combining PET and MRI in one single examination as compared to separate imaging studies.

V. To assess the potential for radiation dose reduction if PET-CT is substituted by PET-MRI, thus avoiding the radiation exposure from the CT-component.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically indicated PET/PET-CT (with or without clinically indicated diagnostic MRI)
  • Presenting with one of the four conditions specified below

    • Fludeoxyglucose F 18 (FDG) avid cancers
    • Cardiac disease (cardiac viability assessment)
    • Neurologic disorders (dementia)
    • Inflammatory disease (for example fever of unknown origin, vasculitis, osteomyelitis)

Exclusion Criteria:

  • Pregnancy and lactation
  • Contraindications to undergo MRI
  • Cardiac pacemaker and metal devices (as specified in a separate MRI Informed consent)
  • Claustrophobia or inability to tolerate MRI examination (lay still for approximately 1 hour and hold breath intermittently)
  • Previously known allergies against MRI contrast agents (exclusion criterion only for contrast enhanced MRI)
  • Renal insufficiency: glomerular filtration rate (GFR) < 40ml/min/1.73) and following European Society of Urogenital Radiology (ESUR) guidelines (exclusion criterion only for contrast enhanced MRI)
  • Individuals who are not willing or capable of giving informed consent or assent (with legal guardian consent)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02084147

Locations
United States, Ohio
Case Comprehensive Cancer Center Not yet recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Pablo Ros    216-983-4829    pablo.ros@uhhospitals.org   
Principal Investigator: Pablo Ros         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Pablo Ros Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02084147     History of Changes
Other Study ID Numbers: CASE16Z12, NCI-2014-00376, CASE16Z12, P30CA043703
Study First Received: March 7, 2014
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Diseases
Dementia
Fever of Unknown Origin
Osteomyelitis
Vasculitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Fever
Body Temperature Changes
Signs and Symptoms
Cardiovascular Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014