Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06170151
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2023-11-28
Brief Title:
Role of18F-FDG PET-CT for Assessing and Predicting Response to Daratumumab and for Prognosis With Multiple Myeloma
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Role of18F-FDG PET-CT for Assessing and Predicting Response to Daratumumab and for Prognosis With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2023-12
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:
Positron Emission Tomography - Computed Tomography PET-CT using fluorine-18 fluorodeoxyglucose is a functional imaging diagnostic tool which is widely used In several neoplastic conditions at initial staging for restaging in suspected disease relapse and for assessing the response to treatment Most patients with multiple myeloma MM exhibit a high-glycolytic activity rate and therefore they are FOG-avid especially at the disease relapse The priceless value of 18F-FOG PET-CT in the therapeutic assessment for several treatment schemes including aSCT has been highlighted by several studies particularly the occurrence of negative PET-CT after a double aSCT in MM patients with clinical complete response or very good partial response positively correlates with favourable PFS and overall survival OS likewise persistence of 18F-FDG avid disease in MM patients achieving a clinical complete response constitutes a poor prognostic factor Primary objective of this prospective observational non-pharmacological multicentric study is to evaluate the role of 18F-FDG PET-CT for assessing early response after 6 months of treatment with daratumumab in patients with relapsedrefractory MM
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