Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05353907
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-04-29
First Post:
2022-02-04
Brief Title:
Dual-Energy Computed Tomography for Improving Imaging Assessment of Multiple Myeloma
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
Dual-Energy Computed Tomography for Improving Imaging Assessment of Multiple Myeloma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-04
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:
DECIMA
Brief Summary:
Up to 30 of patients with newly diagnosedsuspected myeloma cannot undergo or do not tolerate whole body MRI WB-MRI A number of factors may be contributory First WB-MRI protocols can take in excess of 1 hour Patients must remain still within a narrow bore scanner with multiple MRI coils that can be claustrophobic Second there is significant acoustic noise that can be heard despite the use of ear protection Third 80 of patients will experience bone pain or fracture at some point during their illness affecting their comfort within the scanner Fourth patients also have higher anxiety One review reported up to 30 of patients experienced considerable apprehension and up to 10 severe psychological distress when undergoing MRI Finally myeloma is predominantly an illness of the elderly and co-morbid conditions decrease patients ability to tolerate a long scan When WB-MRI cannot be performed NICE recommend whole-body computed tomography WB-CT which the investigators know offers decreased diagnostic performance in terms of marrow assessment and focal lesion detection The investigators believe that using a novel CT technique - dual-energy CT DECT - may offer better diagnostic performance over standard WB-CT in myeloma patients
What the investigators seek to do in this study is to evaluate the sensitivity and specificity of DECT in a cohort of untreated patients and compare the performance of DECT to simulated standard CT data simulated from the DECT and also to WB-MRI reference standard alongside bone marrow biopsy results The investigators will assess both subjective visual analysis of DECT images as well as CT quantitative values for the bone marrow
Secondary objectives include assessment of patient experience across both imaging tests and assessment of intra inter observer variability in subjective visual analysis
What the investigators seek to do in this study is to evaluate the sensitivity and specificity of DECT in a cohort of untreated patients and compare the performance of DECT to simulated standard CT data simulated from the DECT and also to WB-MRI reference standard alongside bone marrow biopsy results The investigators will assess both subjective visual analysis of DECT images as well as CT quantitative values for the bone marrow
Secondary objectives include assessment of patient experience across both imaging tests and assessment of intra inter observer variability in subjective visual analysis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None