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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-02162 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 7754 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| P01CA042045 | U.S. NIH Grant/Contract | View source | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (18F-FLT PET/CT) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo 18F-FLT PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Survival | Time from study entry to death will be recorded | Up to 7 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Rockhill | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 4 patients had 2 scans, 2 patients had 3 scans | Posted | Median | Full Range | percent change | Baseline to up to 1 year after completion of treatment |
|
24 hours after injection of 18F-FLT
This is an imaging study. No adverse events are expected or have been reported due to tracer injection or imaging during the 24 hour monitoring period. All deaths were due to the natural course of cancer after the time period that adverse events were collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hannah Linden | University of Washington | 206-606-2053 | hmlinden@uw.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2016 | Oct 18, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C002854 | alovudine |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Fluorothymidine F-18 | Radiation | Undergo 18F-FLT PET/CT |
|
|
| Positron Emission Tomography | Procedure | Undergo 18F-FLT PET/CT |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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). | 4 patients had 2 scans and 2 had 3 scans. | Posted | Median | Full Range | percent change | 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. | 4 patients had 2 scans, 2 patients had 3 scans | Posted | Median | Full Range | percent change | Baseline to up to 1 year after completion of treatment |
|
|
|
| Primary | Survival | Time from study entry to death will be recorded | All patients with at least one 18F-FLT/CT study | Posted | Median | Full Range | months | 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. | Data not collected for this Outcome Measure | Posted | Up to 7 years |
|
|
| 7 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |