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

NCT03423407 | Terminated FDA Device

• 2 other identifiers: 2017101341R01CA212148-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

PET/CT

Outcome Measures

Primary Outcomes (1)

• Measure the impact of MR acquisition correction sequences for attenuation correction on PET quantitation accuracy

  -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

Study Arms (1)

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)

Interventions

Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI) DEVICE

FDA approved scanner

Also known as: PET/MR, PET/MRI

PET/MR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen at Washington University School of Medicine

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study Officials

• Richard Laforest, Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 6, 2018
• Study Start: December 14, 2017
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)