Metastatic Malignant Neoplasm in the Brain, Primary Brain Neoplasm, Recurrent Brain Neoplasm
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo 18F-FLT PET/CT
RADIATIONFluorothymidine F-18
Undergo 18F-FLT PET/CT
PROCEDUREPositron Emission Tomography
Undergo 18F-FLT PET/CT
Sponsors
National Cancer Institute (NCI)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Measure of FLT Flux | Baseline to up to 1 year after completion of treatment | 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 | Baseline to up to 1 year after completion of treatment | 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 | Baseline to up to 1 year after completion of treatment | 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 | Up to 7 years | Time from study entry to death will be recorded |
| Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria | Up to 7 years | This is clinical response as assessed at physician discretion using standard of care criteria. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Diagnostic (18F-FLT PET/CT) |
|---|---|
| Age, Continuous | 53.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 9 |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
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.
Time frame: Up to 7 years
Population: Data not collected for this Outcome Measure
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.
Time frame: Baseline to up to 1 year after completion of treatment
Population: 4 patients had 2 scans, 2 patients had 3 scans
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2 Diagnostic (18F-FLT PET/CT)Scans | Percentage Change in Measure of FLT Flux | -4 percent change |
| 2 or 3 Diagnostic (18F-FLT PET/CT) Scans | Percentage Change in Measure of FLT Flux | 3 percent change |
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).
Time frame: Baseline to up to 1 year after completion of treatment
Population: 4 patients had 2 scans and 2 had 3 scans.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2 Diagnostic (18F-FLT PET/CT)Scans | Percentage Change in Measure of Reflecting Transport | -11 percent change |
| 2 or 3 Diagnostic (18F-FLT PET/CT) Scans | Percentage Change in Measure of Reflecting Transport | -11 percent change |
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.
Time frame: Baseline to up to 1 year after completion of treatment
Population: 4 patients had 2 scans, 2 patients had 3 scans
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2 Diagnostic (18F-FLT PET/CT)Scans | Percentage Change in Measure of Standard Uptake Value | -14 percent change |
| 2 or 3 Diagnostic (18F-FLT PET/CT) Scans | Percentage Change in Measure of Standard Uptake Value | -10 percent change |
Primary
Survival
Time from study entry to death will be recorded
Time frame: Up to 7 years
Population: All patients with at least one 18F-FLT/CT study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| 2 Diagnostic (18F-FLT PET/CT)Scans | Survival | 23.2 months |