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NCT Number: NCT02167204

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

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.

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Key information

Conditions

Metastatic Malignant Neoplasm in the Brain Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Primary Brain Neoplasm Recurrent Brain Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computed Tomography

Procedure

Undergo 18F-FLT PET/CT

Other names: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

Fluorothymidine F-18

Radiation

Undergo 18F-FLT PET/CT

Other names: 18F-FLT, 3'-Deoxy-3'-(18F) Fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, Fluorothymidine F 18

Positron Emission Tomography

Procedure

Undergo 18F-FLT PET/CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Primary outcomes

  1. Percentage Change in Measure of FLT Flux

    Time frame: 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.

  2. Percentage Change in Measure of Reflecting Transport

    Time frame: 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).

  3. Percentage Change in Measure of Standard Uptake Value

    Time frame: 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.

  4. Survival

    Time frame: Up to 7 years

    Time from study entry to death will be recorded

  5. Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria

    Time frame: Up to 7 years

    This is clinical response as assessed at physician discretion using standard of care criteria.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2014
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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