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Trial record 1 of 1 for:    NCT02167204
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18F-FLT PET/CT in Measuring Cell Proliferation in Patients With Brain Tumors

This study has suspended participant recruitment.
(Accrual is temporarily on hold until a new funding source can be obtained)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT02167204
First received: June 16, 2014
Last updated: October 31, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention
Metastatic Malignant Neoplasm in the Brain
Primary Brain Neoplasm
Recurrent Brain Neoplasm
Procedure: Computed Tomography
Radiation: Fluorothymidine F-18
Procedure: Positron Emission Tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cellular Proliferation Imaging Using [18F] Fluorothymidine (FLT) Positron Emission Tomography (PET) in Brain Tumors

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Clinical response assessed using Revised Assessment in Neuro-Oncology criteria [ Time Frame: Up to 7 years ]
  • Percentage change in measure of FLT flux [ Time Frame: Baseline to up to 1 year after completion of treatment ]
    Log transformations will be considered if the rates of change are highly skewed. In the case of progression, a multivariate logistic regression will be used to produce an analysis of how the combination of standard diagnostics plus the FLT parameters obtained shortly after therapy can best be combined to obtain a prognostic variable for determination of progression.

  • Percentage change in measure of reflecting transport [ Time Frame: Baseline to up to 1 year after completion of treatment ]
    Log transformations will be considered if the rates of change are highly skewed. In the case of progression, a multivariate logistic regression will be used to produce an analysis of how the combination of standard diagnostics plus the FLT parameters obtained shortly after therapy can best be combined to obtain a prognostic variable for determination of progression.

  • Percentage change in measure of standard uptake value [ Time Frame: Baseline to up to 1 year after completion of treatment ]
    Log transformations will be considered if the rates of change are highly skewed. In the case of progression, a multivariate logistic regression will be used to produce an analysis of how the combination of standard diagnostics plus the FLT parameters obtained shortly after therapy can best be combined to obtain a prognostic variable for determination of progression.

  • Survival [ Time Frame: Up to 7 years ]
    Multivariate Cox regression analysis will be used.


Secondary Outcome Measures:
  • Heterogeneity of the within-tumor proliferation [ Time Frame: Up to 1 year after completion of study treatment ]
    Will be obtained by application of the elliptical heterogeneity measure developed by Eary et al.


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (18F-FLT PET/CT)
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.
Procedure: Computed Tomography
Undergo 18F-FLT PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography
Radiation: Fluorothymidine F-18
Undergo 18F-FLT PET/CT
Other Names:
  • 18F-FLT
  • 3'-Deoxy-3'-(18F) Fluorothymidine
  • 3'-deoxy-3'-[18F]fluorothymidine
  • Fluorothymidine F 18
Procedure: Positron Emission Tomography
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02167204

Locations
United States, Washington
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jason Rockhill Fred Hutch/University of Washington Cancer Consortium
  More Information

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT02167204     History of Changes
Other Study ID Numbers: 7754
NCI-2013-02162 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
7754 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P01CA042045 ( US NIH Grant/Contract Award Number )
P30CA015704 ( US NIH Grant/Contract Award Number )
Study First Received: June 16, 2014
Last Updated: October 31, 2016

Additional relevant MeSH terms:
Neoplasms
Brain Neoplasms
Neoplasms, Second Primary
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Alovudine
Dideoxynucleosides
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on April 28, 2017