Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060008
Status:
TERMINATED
Last Update Posted:
2014-04-04
First Post:
2003-05-06
Brief Title:
Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Novel Imaging Modalities For Plexiform Neurofibromas
Status:
TERMINATED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was closed early due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE New imaging procedures such as fludeoxyglucose F 18 positron emission tomography FDG-PET and magnetic resonance MR perfusion imaging may improve the ability to detect disease progression help doctors predict a patients response to treatment and help plan the most effective treatment
PURPOSE This diagnostic trial is studying how well FDG-PET and MR perfusion imaging work in finding disease progression and determining response to treatment in patients with neurofibromatosis 1 and plexiform neurofibroma
PURPOSE This diagnostic trial is studying how well FDG-PET and MR perfusion imaging work in finding disease progression and determining response to treatment in patients with neurofibromatosis 1 and plexiform neurofibroma
Detailed Description:
OBJECTIVES
Determine whether fludeoxyglucose F 18 positron emission tomography FDG-PET and MR perfusion studies can predict plexiform neurofibroma growth rates in patients with neurofibromatosis 1
Determine whether FDG-PET and MR perfusion studies can predict the likelihood of response in patients who are undergoing investigational treatment for plexiform neurofibromas
Identify neuroimaging characteristics that distinguish patients who have responded to therapy from those who have not after completion of treatment
OUTLINE
Stratum 1 Patients undergo MR perfusion scan with gadopentetate dimeglumine and fludeoxyglucose F 18 positron emission tomography FDG-PET at baseline and quantitative MRI evaluation at baseline and 1 year
Stratum 2 Patients undergo quantitative MRI MR perfusion scan with gadopentetate dimeglumine and FDG-PET at baseline and 1 year
PROJECTED ACCRUAL A total of 48 patients 32 for stratum 1 and 16 for stratum 2 will be accrued for this study
Determine whether fludeoxyglucose F 18 positron emission tomography FDG-PET and MR perfusion studies can predict plexiform neurofibroma growth rates in patients with neurofibromatosis 1
Determine whether FDG-PET and MR perfusion studies can predict the likelihood of response in patients who are undergoing investigational treatment for plexiform neurofibromas
Identify neuroimaging characteristics that distinguish patients who have responded to therapy from those who have not after completion of treatment
OUTLINE
Stratum 1 Patients undergo MR perfusion scan with gadopentetate dimeglumine and fludeoxyglucose F 18 positron emission tomography FDG-PET at baseline and quantitative MRI evaluation at baseline and 1 year
Stratum 2 Patients undergo quantitative MRI MR perfusion scan with gadopentetate dimeglumine and FDG-PET at baseline and 1 year
PROJECTED ACCRUAL A total of 48 patients 32 for stratum 1 and 16 for stratum 2 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 |
|---|---|---|---|
| CHP-724 | OTHER | None | None |
| CDR0000299006 | Other Identifier | Childrens Hospital of Philadelphia | None |