18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors

Not Applicable

Completed

Conditions: Primary Brain Neoplasm
Metastatic Malignant Neoplasm in the Brain
Recurrent Brain Neoplasm

Interventions: Procedure: Computed Tomography
Radiation: Fluorothymidine F-18
Procedure: Positron Emission Tomography

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.

Recruitment & Eligibility

Inclusion Criteria

Have a diagnosis or suspected diagnoses of brain tumor (primary, recurrent, or metastatic) by standard clinical diagnosis such as pathology or imaging
Planned for treatment with radiation, chemotherapy and surgical resection or any of these treatment strategies combined

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Diagnostic (18F-FLT PET/CT)	Fluorothymidine F-18	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.
Diagnostic (18F-FLT PET/CT)	Computed Tomography	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.
Diagnostic (18F-FLT PET/CT)	Positron Emission Tomography	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.

Primary Outcome Measures

Name	Time	Method
Percentage Change in Measure of FLT Flux	Baseline to up to 1 year after completion of treatment	The percentage change in the kinetic model parameter of FLT flux (Ki) was recorded. Ki is estimated from parameters derived by fitting the FLT input function and the total blood activity curve to the tissue time-activity curve data.
Percentage Change in Measure of Reflecting Transport	Baseline to up to 1 year after completion of treatment	The percentage change in the kinetic model parameter of FLT transport (K1) was recorded. K1 is defined as the transfer of FLT from blood into tissue (tumor).
Percentage Change in Measure of Standard Uptake Value	Baseline to up to 1 year after completion of treatment	The percentage change in the maximum standard uptake value (SUVmax) was recorded. SUVmax is defined as the amount of FLT uptake in a lesion.
Survival	Up to 7 years	Time from study entry to death will be recorded
Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria	Up to 7 years	This is clinical response as assessed at physician discretion using standard of care criteria.