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

Metastatic Malignant Neoplasm in the Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167204
• Other study ID #: 7754
• Secondary ID: NCI-2013-0216277
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: January 21, 2019

Study information

• Verified date: December 2019
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 21, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• Inability to provide informed consent

• Pregnancy

• Inability to lie still for the imaging study

• Weight over 350 lbs.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Computed Tomography
Undergo 18F-FLT PET/CT

Radiation:
• Fluorothymidine F-18
Undergo 18F-FLT PET/CT

Procedure:
• Positron Emission Tomography
Undergo 18F-FLT PET/CT

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Survival	Time from study entry to death will be recorded	Up to 7 years
Primary	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