Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474533
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-19
Brief Title:
Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
Sponsor:
Thomas Hope
Organization:
University of California San Francisco
Study Overview
Official Title:
Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
Status:
RECRUITING
Status Verified Date:
2024-06
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 is a single center study investigating the use of Fluoroethyltyrosine FET in the detection of brain tumors FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize grade of glial neoplasms
Detailed Description:
PRIMARY OBJECTIVES
1 To determine if FET Positron Emission Tomography PET scan can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent metastatic disease and high-grade gliomas
2 To determine if FET PET scan can differentiate between low-grade and high-grade gliomas in population 2
SECONDARY OBJECTIVES
1 To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology or imaging follow-up in population 1
2 To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology in population 1 with recurrent low-grade gliomas
EXPLORATORY OBJECTIVES
1 To assess relationships between serial FET PET scan and clinical outcome in population 1 with recurrent metastatic disease and gliomas
OUTLINE
Participants will receive a single PET scan lasting for about 40 minutes in an outpatient setting after an injection with FET Adult participants may undergo up to two repeat FET PET scans Patient vital signs will be taken immediately before and after the administration of FET and adverse events will be monitored
1 To determine if FET Positron Emission Tomography PET scan can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent metastatic disease and high-grade gliomas
2 To determine if FET PET scan can differentiate between low-grade and high-grade gliomas in population 2
SECONDARY OBJECTIVES
1 To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology or imaging follow-up in population 1
2 To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology in population 1 with recurrent low-grade gliomas
EXPLORATORY OBJECTIVES
1 To assess relationships between serial FET PET scan and clinical outcome in population 1 with recurrent metastatic disease and gliomas
OUTLINE
Participants will receive a single PET scan lasting for about 40 minutes in an outpatient setting after an injection with FET Adult participants may undergo up to two repeat FET PET scans Patient vital signs will be taken immediately before and after the administration of FET and adverse events will be monitored
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-04996 | REGISTRY | None | None |