NCT03603925

Enhancing SUV Accuracy of PET/MR for Clinical Trial Qualification

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Positron Emission Tomography-Magnetic Resonance (PET-MR)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-17
• Primary completion: 2021-04-07
• Completion: 2021-04-07
• First posted: 2018-07-27
• Last updated: 2021-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study