Clinical trial NCT02167204: 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
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Malignant Neoplasm in the Brain
Primary Brain Neoplasm
Recurrent Brain Neoplasm
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-06-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Percentage Change in Measure of FLT Flux
timeFrame: Baseline to up to 1 year after completion of treatment
measure: Percentage Change in Measure of Reflecting Transport
timeFrame: Baseline to up to 1 year after completion of treatment
measure: Percentage Change in Measure of Standard Uptake Value
timeFrame: Baseline to up to 1 year after completion of treatment
measure: Survival
timeFrame: Up to 7 years
measure: Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria
timeFrame: Up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jason Rockhill
role: PRINCIPAL_INVESTIGATOR
References: