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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cellular Proliferation Imaging Using [18F] Fluorothymidine (FLT) Positron Emission Tomography (PET) in Brain Tumors

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

Intervention / Treatment
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* Procedure: Computed Tomography
* Radiation: Fluorothymidine F-18
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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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: Inability to provide informed consent Pregnancy Inability to lie still for the imaging study Weight over 350 lbs.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (18F-FLT PET/CT)<br>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. | Procedure: Computed Tomography<br>* Undergo 18F-FLT PET/CT<br>* Other names: tomography;Radiation: Fluorothymidine F-18<br>* Undergo 18F-FLT PET/CT<br>* Other names: Fluorothymidine F 18;Procedure: Positron Emission Tomography<br>* Undergo 18F-FLT PET/CT<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Measure of FLT Flux | 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. | Baseline to up to 1 year after completion of treatment | 
| Percentage Change in Measure of Reflecting Transport | 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). | Baseline to up to 1 year after completion of treatment | 
| Percentage Change in Measure of Standard Uptake Value | The percentage change in the maximum standard uptake value (SUVmax) was recorded. SUVmax is defined as the amount of FLT uptake in a lesion. | Baseline to up to 1 year after completion of treatment | 
| Survival | Time from study entry to death will be recorded | Up to 7 years | 
| Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria | This is clinical response as assessed at physician discretion using standard of care criteria. | Up to 7 years |