Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752267
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2021-02-08
Brief Title:
18F-FMAU PETCT and MRI for the Detection of Brain Tumors in Patients With Brain Cancer or Brain Metastases
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Novel Dynamic PET Kinetics and MRI Radiomics Analyses in Brain Tumors
Status:
COMPLETED
Status Verified Date:
2024-05
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:
This early phase I trial tests the use of a radioactive tracer a drug that is visible during an imaging test known as 18F-FMAU for imaging with positron emission tomographycomputed tomography PETCT in patients with brain cancer or cancer that has spread to the brain brain metastases A PETCT scan is an imaging test that uses a small amount of radioactive tracer given through the vein to take detailed pictures of areas inside the body where the tracer is taken up 18F-FMAU may also help find the cancer and how far the disease has spread Magnetic resonance imaging MRI is a type of imaging test used to diagnose brain tumors 18F-FMAU PETCT in addition to MRI may make the finding and diagnosing of brain tumor easier
Detailed Description:
PRIMARY OBJECTIVES
I Assess the correlation between multiparametric magnetic resonance imaging mpMRI radiomics and dynamic 2-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil FMAU PET kinetic analysis parameters
II Explore the different pattern in radiomics mpMRI and FMAU PET kinetic analysis parameters between patients with presence or absence of recurrent tumor
OUTLINE
Patients receive 18F-FMAU intravenously IV and undergo a PETCT scan over 60 minutes Patients then undergo standard of care mpMRI over approximately 45 minutes
After completion of study intervention patients are followed up at 24-96 hours after their 18F-FMAU PETCT scan
I Assess the correlation between multiparametric magnetic resonance imaging mpMRI radiomics and dynamic 2-fluoro-5-methyl-1-beta-D-arabinofuranosyluracil FMAU PET kinetic analysis parameters
II Explore the different pattern in radiomics mpMRI and FMAU PET kinetic analysis parameters between patients with presence or absence of recurrent tumor
OUTLINE
Patients receive 18F-FMAU intravenously IV and undergo a PETCT scan over 60 minutes Patients then undergo standard of care mpMRI over approximately 45 minutes
After completion of study intervention patients are followed up at 24-96 hours after their 18F-FMAU PETCT scan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| P30CA014089 | NIH | USC Norris Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA014089 |
| NCI-2021-00706 | REGISTRY | None | None |
| 6B-20-1 | OTHER | None | None |