Nervous System Diseases

Behaviors and Mental Disorders

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Wounds and Injuries

Infections

Musculoskeletal Diseases

Rare Diseases

Dementia

Heart Diseases

Hyperthermia

Fever

Vasculitis

Osteomyelitis

Fever of Unknown Origin

Vascular Diseases

Communicable Diseases

Bone Diseases

Bone Diseases, Infectious

Body Temperature Changes

Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.

positron emission tomography

computed tomography

magnetic resonance imaging

Pablo Ros, MD, MPH, PhD

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.

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.

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

PET-MRI: Evaluation, Optimization and Clinical Implementation

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 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.

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.

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.

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

National Cancer Institute (NCI)

Case Comprehensive Cancer Center

Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.

positron emission tomography: Undergo PET

computed tomography: Undergo CT

magnetic resonance imaging: Undergo MRI

PET-CT and PET-MRI

10-19 years

20-29 years

30-39 years

40-49 years

50-59 years

60-69 years

70-79 years

80-89 years

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

No data was obtained from this study group as the patient cohort was inconsistent

Spots Global Cancer Trial Database for fdg avid cancers