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

• Sponsor: Case Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02084147
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 72
• Location: 1
• Arm: 1
• Actual Duration (Months): 66.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease; Dementia; Inflammatory Disease; Fever of Unknown Origin; Vasculitis; Osteomyelitis; FDG Avid Cancers	Device: positron emission tomography; Device: computed tomography; Device: magnetic resonance imaging	N/A

Detailed Description

PRIMARY OBJECTIVES:

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

2. 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.

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

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

5. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: PET-MRI: Evaluation, Optimization and Clinical Implementation
• Actual Study Start Date: Mar 7, 2013
• Actual Primary Completion Date: Sep 14, 2016
• Actual Study Completion Date: Oct 2, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PET-CT and PET-MRI Patients undergo PET-CT over approximately 30 minutes and PET-MRI over approximately 45-90 minutes.	Device: positron emission tomography; Undergo PET; Other Names: FDG-PET PET PET scan tomography, emission computed ; Device: computed tomography; Undergo CT; Other Names: tomography, computed CT ; Device: magnetic resonance imaging; Undergo MRI; Other Names: MRI NMR imaging NMRI nuclear magnetic resonance imaging

Outcome Measures

Primary Outcome Measures

1. Overall Image Quality Scores [Day 1]

   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.

2. Lesion Based Standard Uptake Values (SUV) [Day 1]

   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.

3. Area Under the Receiver Operating Characteristic Curve [Day 1]

   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.

4. Time Effort Associated With the PET-MRI Versus PET-CT With MRI [Day 1]

   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.

5. Radiation Dose Reduction With PET-MRI [Day 1]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Case Comprehensive Cancer Center	Cleveland	Ohio	United States	44106-5065

Sponsors and Collaborators

• Case Comprehensive Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Pablo Ros, MD, MPH, PhD, Case Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT02084147
• Other Study ID Numbers: CASE16Z12; NCI-2014-00376; CASE16Z12; P30CA043703
• First Posted: Mar 11, 2014
• Last Update Posted: Oct 29, 2019
• Last Verified: Oct 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Osteomyelitis; Vasculitis; Heart Diseases; Fever of Unknown Origin

Study Results

Participant Flow

Arm/Group Title	PET-CT and PET-MRI
Arm/Group Description	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
Period Title: Overall Study
STARTED	72
COMPLETED	72
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	PET-CT and PET-MRI
Arm/Group Description	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
Overall Participants	72
Age, Customized (Count of Participants)
10-19 years	4 5.6%
20-29 years	1 1.4%
30-39 years	3 4.2%
40-49 years	4 5.6%
50-59 years	25 34.7%
60-69 years	17 23.6%
70-79 years	14 19.4%
80-89 years	4 5.6%
Sex: Female, Male (Count of Participants)
Female	30 41.7%
Male	42 58.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	31 43.1%
Unknown or Not Reported	41 56.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	6 8.3%
White	50 69.4%
More than one race	8 11.1%
Unknown or Not Reported	8 11.1%
Region of Enrollment (participants) [Number]
United States	72 100%

Outcome Measures

1. Primary Outcome

Title	Overall Image Quality Scores
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	PET-CT and PET-MRI
Arm/Group Description	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
Measure Participants	0

2. Primary Outcome

Title	Lesion Based Standard Uptake Values (SUV)
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	PET-CT and PET-MRI
Arm/Group Description	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
Measure Participants	0

3. Primary Outcome

Title	Area Under the Receiver Operating Characteristic Curve
Description	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 Frame	Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	PET-CT and PET-MRI
Arm/Group Description	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
Measure Participants	0

4. Primary Outcome

Title	Time Effort Associated With the PET-MRI Versus PET-CT With MRI
Description	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.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	PET-CT and PET-MRI
Arm/Group Description	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
Measure Participants	0

5. Primary Outcome

Title	Radiation Dose Reduction With PET-MRI
Description	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
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	PET-CT and PET-MRI
Arm/Group Description	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
Measure Participants	0

Adverse Events

Time Frame	At time of scan
Arm/Group Title	PET-CT and PET-MRI
Arm/Group Description	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
All Cause Mortality
	PET-CT and PET-MRI
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PET-CT and PET-MRI
	Affected / at Risk (%)	# Events
Total	0/72 (0%)
Other (Not Including Serious) Adverse Events
	PET-CT and PET-MRI
	Affected / at Risk (%)	# Events
Total	0/72 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.