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

University of Washington9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Interventions

Computed TomographyPROCEDURE

Undergo 18F-FLT PET/CT

Fluorothymidine F-18RADIATION

Undergo 18F-FLT PET/CT

Positron Emission TomographyPROCEDURE

Undergo 18F-FLT PET/CT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: Baseline to up to 1 year after completion of treatment

Survival

Time from study entry to death will be recorded

Time frame: 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.

Time frame: Up to 7 years

Data from ClinicalTrials.gov

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