Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109889
Status:
TERMINATED
Last Update Posted:
2017-04-24
First Post:
2005-05-03
Brief Title:
S0340 MRI and Fludeoxyglucose F18 PET in Diagnosing Solitary Plasmacytoma
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Prospective Observational Study of Patients With Solitary Plasmacytoma Using a Modified Staging System Supplemented by an MRI and Whole Body FDG-PET Scan
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Diagnostic procedures such as magnetic resonance imaging MRI and fludeoxyglucose F 18 positron emission tomography 18FDG-PET may help diagnose solitary plasmacytoma
PURPOSE This clinical trial is studying MRI and 18FDG-PET to see how well they work in diagnosing patients with solitary plasmacytoma
PURPOSE This clinical trial is studying MRI and 18FDG-PET to see how well they work in diagnosing patients with solitary plasmacytoma
Detailed Description:
OBJECTIVES
Determine the proportion of patients who are misclassified as true solitary plasmacytoma by MRI and whole-body fludeoxyglucose F 18 positron emission tomography as a supplement to imaging with skeletal survey
Determine the feasibility of accruing patients to this study
Determine preliminarily biological correlates and prognostic groups that may relate to progression to symptomatic disease in patients undergoing these imaging procedures
Correlate germline genetic polymorphisms with overall clinical course in patients undergoing these imaging procedures
OUTLINE This is a multicenter study
Within 28 days after study entry patients undergo gadolinium MRI of the head spine and pelvis and other sites if indicated Patients then receive fludeoxyglucose F 18 IV followed 90 minutes later by whole-body positron emission tomography 18FDG-PET OR whole-body CT scanPET Patients with a confirmed diagnosis of solitary plasmacytoma undergo MRI and 18FDG-PET as above at 1 year and then annually for 10 years in the absence of disease progression ie change of status to solitary plasmacytoma with active myeloma or biopsy confirmed stage IB or higher multiple myeloma
After completion of study procedures patients are followed every 6 months for 10 years
PROJECTED ACCRUAL A total of 110 patients will be accrued for this study
Determine the proportion of patients who are misclassified as true solitary plasmacytoma by MRI and whole-body fludeoxyglucose F 18 positron emission tomography as a supplement to imaging with skeletal survey
Determine the feasibility of accruing patients to this study
Determine preliminarily biological correlates and prognostic groups that may relate to progression to symptomatic disease in patients undergoing these imaging procedures
Correlate germline genetic polymorphisms with overall clinical course in patients undergoing these imaging procedures
OUTLINE This is a multicenter study
Within 28 days after study entry patients undergo gadolinium MRI of the head spine and pelvis and other sites if indicated Patients then receive fludeoxyglucose F 18 IV followed 90 minutes later by whole-body positron emission tomography 18FDG-PET OR whole-body CT scanPET Patients with a confirmed diagnosis of solitary plasmacytoma undergo MRI and 18FDG-PET as above at 1 year and then annually for 10 years in the absence of disease progression ie change of status to solitary plasmacytoma with active myeloma or biopsy confirmed stage IB or higher multiple myeloma
After completion of study procedures patients are followed every 6 months for 10 years
PROJECTED ACCRUAL A total of 110 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA032102 | NIH | None | None |
| S0340 | OTHER | SWOG | httpsreporternihgovquickSearchU10CA032102 |