Clinical Trial: NCT03603925 - My Cancer Genome

NCT03603925

Description:

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.

Recruiting Status:

Recruiting

URL:

https://clinicaltrials.gov/show/NCT03603925

Trial Eligibility

Document

Title

Brief Title: Enhancing SUV Accuracy of PET/MR for Clinical Trial Qualification
Official Title: Enhancing SUV Accuracy of PET/MR for Clinical Trial Qualification

Clinical Trial IDs

ORG STUDY ID: CASE3Y18
NCT ID: NCT03603925

Conditions

Positron Emission Tomography-Magnetic Resonance (PET-MR)

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
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.

Eligibility Criteria

        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).

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Quantitative agreement between measured CT and CT synthesized from MR data (Hounsfield Units)
Time Frame:	Up to 3 hours after beginning scan
Safety Issue:
Description:	Demonstrate quantitative agreement between measured CT and CT synthesized from MR data

Secondary Outcome Measures

Measure:	Percent difference in Standardized Uptake Values (SUVs) in PET/CT scans compared to PET/MR scans
Time Frame:	Up to 3 hours after beginning scan
Safety Issue:
Description:	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.

Details

Phase:
Primary Purpose:	Observational
Overall Status:	Recruiting
Lead Sponsor:	Case Comprehensive Cancer Center

Trial Keywords

Computed tomography
standardized update values

Last Updated

April 30, 2021

Clinical Trials /

Enhancing SUV Accuracy of PET/MR for Clinical Trial Qualification