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

Dementia Clinical Trial

Official title:

PET-MRI: Evaluation, Optimization and Clinical Implementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084147
• Other study ID #: CASE16Z12
• Secondary ID: NCI-2014-00376CA
• Status: Completed
• Phase: N/A
• Start date: March 7, 2013
• Est. completion date: October 2, 2018

Study information

• Verified date: October 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2, 2018
• Est. primary completion date: September 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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/1.73m^2 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)

Related Conditions & MeSH terms

• Cardiac Disease
• Dementia
• FDG Avid Cancers
• Fever of Unknown Origin
• Heart Diseases
• Inflammatory Disease
• Osteomyelitis
• Vasculitis

Intervention

Device:
• positron emission tomography
Undergo PET
• computed tomography
Undergo CT
• magnetic resonance imaging
Undergo MRI

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Image Quality Scores	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.	Day 1
Primary	Lesion Based Standard Uptake Values (SUV)	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.	Day 1
Primary	Area Under the Receiver Operating Characteristic Curve	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.	Day 1
Primary	Time Effort Associated With the PET-MRI Versus PET-CT With MRI	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.	Day 1
Primary	Radiation Dose Reduction With PET-MRI	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	Day 1