Enhancing SUV Accuracy of PET/MR for Clinical Trial Qualification

Standardized Uptake Values (SUVs), normalized activity concentration, measured using PET/MR have inaccuracies ≥ 20% which exceeds National Cancer Institute / American College of Radiology Imaging Network (NCI/ACRIN), Radiological Society of North America / Quantitative Imaging Biomarkers Alliance (RSNA/QIBA) specifications and disqualifies PET/MR from multicenter or cooperative group clinical trials. High inaccuracy is primarily due to poor attenuation correction (AC) owing to lack of computed tomography (CT) data. This study will develop acquisition and analyses methods to synthesize CT images from MR data that can be used to achieve SUVs that are within 5% of those obtained using PET/CT (reference standard), thus meeting accuracy requirements needed to qualify for multicenter trials.

The overall goal of this research project is to validate clinically practical methods for producing MR-based attenuation correction information which is needed to produce quantitatively accurate PET images from a PET/MR scanner. Existing commercial PET/MR systems use methods that are inaccurate.

Study Overview

• Status: Completed
• Conditions: Positron Emission Tomography-Magnetic Resonance (PET-MR)
• Intervention / Treatment: Diagnostic test: Positron Emission Test / Magnetic Resonance (PET/MR); Diagnostic test: Positron Emission Test / Computed Tomography (PET/CT)

Detailed Description

Objective The primary objective is to demonstrate that, using the new acquisition and analysis methods for MR-AC, PET SUVs in lesions and normal tissues can be measured using PET/MR and be within 5% agreement of those measured using PET/CT.

The secondary objective is to demonstrate visual and quantitative agreement between synthesized CT images generated from MR data and the reference, measured CT images.

Study Design This study would like to enroll patients receiving a clinically indicated PET/CT scan. The patients will be asked to agree to a receive research PET/MR scan within the study which requires additional time and potential MR risks for the patient. It does not entail extra injections or radiation exposure. Research acquisition and processing will be performed on the PET/MR data to create PET images that are expected to have quantitatively accurate SUVs. These will be compared to SUVs from the clinical PET/CT which will serve as the reference standard.

Outcome By bringing together cutting-edge advances in both MR acquisition and image analyses, the successful completion of these aims will achieve SUVs that are within 5% of those obtained with PET/CT (reference standard) with clinically appropriate acquisition time, image quality, and diagnostic accuracy, so that PET/MR systems meet SUV accuracy requirements needed to qualify for cooperative group clinical trials.

• Study Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving PET/CT at University Hospitals Cleveland Medical Center (UHCMC) for a clinical indication

Description

Inclusion Criteria:

• Receiving PET/CT at University Hospitals Cleveland Medical Center (UHCMC) for a clinical indication
• No Contraindications to undergo MR as assessed using University Hospitals (UH) Radiology standard MR assessment form
• Has the ability to understand and willingness to sign a written informed consent
• The circumference of the volunteer in the body section, as determined using a measuring tape, to be scanned must be less than or equal to 110 cm to avoid field of view limitations on the PET/MR

Exclusion Criteria:

• Patient size or circumference greater than the MR gantry of the PET/MR.
• Pregnancy or lactation.
• Contraindications to undergo MR as assessed using UH Radiology standard MR assessment form.
• Claustrophobia or inability to tolerate MR examination (lay still for approximately 1 hour and hold breath intermittently).
• Individuals who are not willing or capable of giving informed consent or assent (with legal guardian consent).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

PET/MR + PET/CT; The interventions for participating in this research are centered around steps needed to safely and ethically collect a research PET/MR scan following a standard-of-care PET/CT scan. The patient will be imaged in at least one of several standard anatomic areas: head/neck, thorax, abdomen, pelvis or whole-body.

Diagnostic test: Positron Emission Test / Magnetic Resonance (PET/MR); The Philips Ingenuity PET/MR is used for research scanning. Patients receiving a clinically indicated PET/CT, will be approached to be included in this study. There is no special preparation other than that needed for the prerequisite PET/CT scanning. At the completion of the PET/CT scanning, the subject will be taken to the PET/MR scanner, which is in close in proximity, for research scanning. The research scanning would take up to one hour or as tolerated.; Diagnostic test: Positron Emission Test / Computed Tomography (PET/CT); Patients will receive PET / CT imaging for the detection of cancer or other clinically indicated anomalies. The completed study visit is expected to take approximately 2 hours and not longer than 3 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative agreement between measured CT and CT synthesized from MR data (Hounsfield Units)	Demonstrate quantitative agreement between measured CT and CT synthesized from MR data	Up to 3 hours after beginning scan
Quantitative agreement in the derived linear attenuation coefficients at 511 kilo electro volts (keV).	Demonstrate quantitative agreement in the derived linear attenuation coefficients at 511 keV.	Up to 3 hours after beginning scan

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent difference in Standardized Uptake Values (SUVs) in PET/CT scans compared to PET/MR scans	Demonstrate that SUVs in lesions and normal tissues measured using MR-based attenuation correction (MR-AC) are within 5% of those measured using PET/CT.	Up to 3 hours after beginning scan

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Raymond F. Muzic, PhD, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Actual): April 7, 2021
• Study Completion (Actual): April 7, 2021

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Computed tomography; standardized update values
• Other Study ID Numbers: CASE3Y18; R01CA196687 (U.S. NIH Grant/Contract)

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