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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computed Tomography
Fluorothymidine F-18
Positron Emission Tomography
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastatic Malignant Neoplasm in the Brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (18F-FLT PET/CT)

Arm 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.

Outcomes

Primary Outcome Measures

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.
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).
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.
Survival
Time from study entry to death will be recorded
Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria
This is clinical response as assessed at physician discretion using standard of care criteria.

Secondary Outcome Measures

Full Information

First Posted
June 16, 2014
Last Updated
January 8, 2020
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02167204
Brief Title
18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors
Official Title
Cellular Proliferation Imaging Using [18F] Fluorothymidine (FLT) Positron Emission Tomography (PET) in Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
January 21, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Malignant Neoplasm in the Brain, Primary Brain Neoplasm, Recurrent Brain Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (18F-FLT PET/CT)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Intervention Description
Undergo 18F-FLT PET/CT
Intervention Type
Radiation
Intervention Name(s)
Fluorothymidine F-18
Other Intervention Name(s)
18F-FLT, 3'-Deoxy-3'-(18F) Fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, Fluorothymidine F 18
Intervention Description
Undergo 18F-FLT PET/CT
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo 18F-FLT PET/CT
Primary Outcome Measure Information:
Title
Percentage Change in Measure of FLT Flux
Description
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
Title
Percentage Change in Measure of Reflecting Transport
Description
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
Title
Percentage Change in Measure of Standard Uptake Value
Description
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
Title
Survival
Description
Time from study entry to death will be recorded
Time Frame
Up to 7 years
Title
Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria
Description
This is clinical response as assessed at physician discretion using standard of care criteria.
Time Frame
Up to 7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Rockhill
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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