Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT02167204
Status:
COMPLETED
Last Update Posted:
2020-01-13
First Post:
2014-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Cellular Proliferation Imaging Using [18F] Fluorothymidine (FLT) Positron Emission Tomography (PET) in Brain Tumors
Status:
COMPLETED
Status Verified Date:
2019-12
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 pilot clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring cell proliferation in patients with brain tumors. Comparing results of diagnostic procedures done before, during, and after treatment may help doctors measure tumor growth and plan the best treatment.
Detailed Description:
PRIMARY OBJECTIVES:
I. Using FLT PET/CT as a measure of cellular proliferation, assess tissue proliferation in disease sites of brain tumor patients before therapy (surgery, chemotherapy or radiotherapy or any combination of these).
II. Determine level of change in cellular proliferation compared with baseline (scan 1) in brain tumors at mid-therapy (scan 2), after completion of therapy (scan 3) and in the clinical follow-up period (scan 4), when possible.
III. Correlate levels of cellular proliferation measured by FLT PET/CT at baseline and treatment-induced changes in brain tumor proliferation with clinical response status (clinical categories are complete remission, lesser degrees of response/stable disease, and no response).
SECONDARY OBJECTIVES:
I. Assess spatial heterogeneity of FLT uptake to identify local differences in brain tumor disease burden.
OUTLINE:
Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.
After completion of study, patients are followed for up to 7 years.
I. Using FLT PET/CT as a measure of cellular proliferation, assess tissue proliferation in disease sites of brain tumor patients before therapy (surgery, chemotherapy or radiotherapy or any combination of these).
II. Determine level of change in cellular proliferation compared with baseline (scan 1) in brain tumors at mid-therapy (scan 2), after completion of therapy (scan 3) and in the clinical follow-up period (scan 4), when possible.
III. Correlate levels of cellular proliferation measured by FLT PET/CT at baseline and treatment-induced changes in brain tumor proliferation with clinical response status (clinical categories are complete remission, lesser degrees of response/stable disease, and no response).
SECONDARY OBJECTIVES:
I. Assess spatial heterogeneity of FLT uptake to identify local differences in brain tumor disease burden.
OUTLINE:
Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.
After completion of study, patients are followed for up to 7 years.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2013-02162 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 7754 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View | |
| P01CA042045 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA015704 | NIH | None | https://reporter.nih.gov/quic… | View |