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

May 11, 2022 updated by: Washington University School of Medicine
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients seen at Washington University School of Medicine

Description

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

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PET/MR
  • 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
Device: Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)
FDA approved scanner
Other Names:
  • PET/MR
  • PET/MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure the impact of MR acquisition correction sequences for attenuation correction on PET quantitation accuracy
Time Frame: 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.
At the time of the MRI scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Richard Laforest, Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2017

Primary Completion (Actual)

March 2, 2020

Study Completion (Actual)

March 2, 2020

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

January 31, 2018

First Posted (Actual)

February 6, 2018

Study Record Updates

Last Update Posted (Actual)

May 16, 2022

Last Update Submitted That Met QC Criteria

May 11, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 201710134
  • 1R01CA212148-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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