18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors
Conditions
Malignant Primary Brain Neoplasm - Metastatic Malignant Neoplasm to the Brain - Recurrent Adult Brain Neoplasm
Conditions: official terms
Brain Neoplasms - Neoplasms - Neoplasms, Second Primary
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Fluorothymidine F-18 Type: Radiation
Name: Positron Emission Tomography Type: Procedure
Name: Computed Tomography Type: Procedure
Overall Status
Recruiting
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 (chemotherapy or radiotherapy or both concurrently).

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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Have a diagnosis of malignant brain tumor (primary, recurrent, or metastatic) by standard clinical-pathological diagnosis

- Planned for treatment with radiation, chemotherapy and surgical resection or any of these treatment strategies combined

Exclusion Criteria:

- Inability to provide informed consent

- Pregnancy

- Inability to lie still for the imaging study

- Weight over 350 lbs.
Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Status: Recruiting
Contact: Jason Rockhill - 206-598-4121
Start Date
November 2012
Sponsors
University of Washington
Source
University of Washington
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page