Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT06474533
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2024-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
Sponsor:
Thomas Hope
Organization:
Study Overview
Official Title:
Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
Status:
RECRUITING
Status Verified Date:
2025-03
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. Adverse events will be recorded.
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. Adverse events will be recorded.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-04996 | REGISTRY | NCI Clinical Trials Reporting Program (CTRP) | View |