Enhancing SUV Accuracy of PET/MR for Clinical Trial Qualification
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|ClinicalTrials.gov Identifier: NCT03603925|
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : April 30, 2021
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.
|Condition or disease||Intervention/treatment|
|Positron Emission Tomography-Magnetic Resonance (PET-MR)||Diagnostic Test: Positron Emission Test / Magnetic Resonance (PET/MR) Diagnostic Test: Positron Emission Test / Computed Tomography (PET/CT)|
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|
|Estimated Enrollment :||100 participants|
|Official Title:||Enhancing SUV Accuracy of PET/MR for Clinical Trial Qualification|
|Actual Study Start Date :||June 17, 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
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.
- Quantitative agreement between measured CT and CT synthesized from MR data (Hounsfield Units) [ Time Frame: Up to 3 hours after beginning scan ]Demonstrate quantitative agreement between measured CT and CT synthesized from MR data
- Quantitative agreement in the derived linear attenuation coefficients at 511 kilo electro volts (keV). [ Time Frame: Up to 3 hours after beginning scan ]Demonstrate quantitative agreement in the derived linear attenuation coefficients at 511 keV.
- 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603925
|Contact: Raymond F. Muzic, PhD||216-844-3543||Raymond.Muzic@uhhospitals.org|
|United States, Ohio|
|University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Raymond F. Muzic, PhD 800-641-2422 CTUReferral@uhhospitals.org|
|Principal Investigator: Raymond F. Muzic, PhD|
|Principal Investigator:||Raymond F. Muzic, PhD||University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|