Evaluation of Attenuation Correction Accuracy in Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)

Terminated

• Conditions: PET/CT
• Interventions: Device: Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)

• Registration Number: NCT03423407
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this research proposal is to establish a mechanism to develop tools that will allow the investigators to measure the impact of magnetic resonance (MR) acquisition correction sequences for attenuation correction on positron emission tomography (PET) quantitation accuracy.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-14
• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-01-31
• Study First Posted: 2018-02-06
• Primary Completion: 2020-03-02
• Study Completion: 2020-03-02
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-11
• Last Update Posted: 2022-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Participant must be ≥ 18 years of age
• Participant can be a male or a non-pregnant female.
• Successful completion of MRI screening form
• Participant must have undergone a PET/CT examination with injection of a standard dose of 18F-fluorodeoxyglucose (FDG) or other PET tracer with a half-life greater than one hour either for clinical or research purposes within 3 hrs of the proposed PET-MRI examination.
• Participant will be fully informed and has personally signed and dated the written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) provisions

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Exclusion Criteria

• Subjects for whom exposure to a strong magnetic field would be a health risk (e.g., subjects with cardiac pacemakers or non-MR compatible metallic implants)
• Women who are pregnant.
• Subjects who require sedation to participate will be excluded.
• Patient/participant has a medical condition which in the judgment of the investigator might make supine positioning for the duration of the scan unsafe, such as (but not limited to) congestive heart failure or significant pulmonary disease.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PET/MR	Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)	* Participants will be scanned on a PET-MRI scanner which is FDA-approved and will operate within FDA-approved guidelines. * Participants will be asked to lie still within the scanner for up to 90 minutes

Primary Outcome Measures

Name	Time	Method
Measure the impact of MR acquisition correction sequences for attenuation correction on PET quantitation accuracy	At the time of the MRI scan	-PET images from PET/MRI with the MR derived attenuation correction will be compared to images generated with the CT attenuation correction from the standard of care PET/CT scan.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States