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

University of Washington

Status: Completed

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

Treatments: Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Radiation: Fluorothymidine F-18

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02167204

NCI-2013-02162 (Registry Identifier)

7754 (Other Identifier)

P01CA042045 (U.S. NIH Grant/Contract)

P30CA015704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Diagnostic (18F-FLT PET/CT)

Experimental group

Description:

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.

Treatment:

Radiation: Fluorothymidine F-18

Procedure: Positron Emission Tomography

Procedure: Computed Tomography