Ignite Creation Date:
2024-05-06 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 12:50 PM
Study NCT ID:
NCT03603925
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2018-07-19
Brief Title:
Enhancing SUV Accuracy of PETMR for Clinical Trial Qualification
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Enhancing SUV Accuracy of PETMR for Clinical Trial Qualification
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Standardized Uptake Values SUVs normalized activity concentration measured using PETMR have inaccuracies 20 which exceeds National Cancer Institute American College of Radiology Imaging Network NCIACRIN Radiological Society of North America Quantitative Imaging Biomarkers Alliance RSNAQIBA specifications and disqualifies PETMR 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 PETCT 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 PETMR scanner Existing commercial PETMR systems use methods that are inaccurate
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 PETMR scanner Existing commercial PETMR 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 PETMR and be within 5 agreement of those measured using PETCT
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 PETCT scan The patients will be asked to agree to a receive research PETMR 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 PETMR data to create PET images that are expected to have quantitatively accurate SUVs These will be compared to SUVs from the clinical PETCT 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 PETCT reference standard with clinically appropriate acquisition time image quality and diagnostic accuracy so that PETMR systems meet SUV accuracy requirements needed to qualify for cooperative group clinical trials
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 PETCT scan The patients will be asked to agree to a receive research PETMR 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 PETMR data to create PET images that are expected to have quantitatively accurate SUVs These will be compared to SUVs from the clinical PETCT 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 PETCT reference standard with clinically appropriate acquisition time image quality and diagnostic accuracy so that PETMR systems meet SUV accuracy requirements needed to qualify for cooperative group clinical trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA196687 | NIH | None | httpsreporternihgovquickSearchR01CA196687 |