Breast Cancer
Conditions
Brief summary
The purpose of this study is to develop Positron Emission Tomography (PET) - Computed Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast cancer.
Interventions
RADIATIONRadiopharmaceutical Administration [18F]-FDG
Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.
RADIATIONRadiopharmaceutical: [18F]-FLT
Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.
Sponsors
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have histologically proven breast cancer * Subjects are being considered for preoperative chemotherapy * Subjects must be ≥ 18 years old. Sensor Sub-Study Only * Palpable subcutaneous or known disease with one surface \<1cm below surface of skin. * A subset of patients who have a mass located on any surface of the breast that is accessible for Lucerno sensor placement will have additional testing.
Exclusion criteria
* Children will be excluded from this study. * Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology PET Procedure Screening Form will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential). * Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study. * Intraluminal lesions will be excluded from the sensor sub-study. * Non biopsy proven malignancy will be excluded from this study. * Palpable subcutaneous or known disease with one surface \>1cm below surface of skin will be excluded from the sensor sub-study. * Draining or exposed malignant tumor will be excluded from the sensor sub-study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR) | up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery) | The quantitative measures of standard uptake value (SULpeak and SULmax, prone and supine position) from PET were obtained. SUV = (Tracer activity in tissue)/(Injected radiotracer dose/patient weight or lean body mass) with unit microcuries/g/(millicuries/kg) (no unit after simplification). The SUV was averaged over the tumor regions. These averages were computed for each patient at each time point. All patients were were planned to be scanned three times: prior to treatment, during treatment and at the end of treatment. The change of SUV was calculated as the end of treatment value minus the pre-treatment value. Then the difference in the change between the responders and non-responders were estimated using Wilcoxon rank sum test. The pseudomedians and nonparametric confidence intervals for the difference (change of non-responders minus the change of responders) were reported for parameters SULpeak and SULmax measured for different positions. Pathological response were measured at the |
Secondary
| Measure | Time frame |
|---|---|
| Compare and Combine Magnetic Resonance Imaging (MRIs) (Obtained From Study BRE0588) and Positron Emission Tomography/ Computed Tomography (PET/CT) Methods to Develop a Robust Assessment of Tumor Status. | 48 months |
Countries
United States
Participant flow
Recruitment details
This trial opened to accrual on 10/13/2010 and closed to accrual on 4/14/2015.
Pre-assignment details
No participants were enrolled onto the Fluorodeoxythymidine PET/CT (FLT-PET/CT) arm because this trial closed to accrual early due to slow accrual.
Participants by arm
| Arm | Count |
|---|---|
| Fluorodeoxyglucose PET/CT (FDG-PET/CT) A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical Administration \[18F\]-FDG: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection. | 50 |
| Fluorodeoxythymidine PET/CT (FLT-PET/CT) A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.
Radiopharmaceutical: \[18F\]-FLT: Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection. | 0 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Death | 1 | 0 |
| Overall Study | ineligible;metastasis | 3 | 0 |
| Overall Study | missed view/scan | 1 | 0 |
| Overall Study | scheduling | 6 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Total | Fluorodeoxyglucose PET/CT (FDG-PET/CT) | Fluorodeoxythymidine PET/CT (FLT-PET/CT) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | — |
| Age, Categorical Between 18 and 65 years | 46 Participants | 46 Participants | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 48 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | — |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Black or African American | 11 Participants | 11 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | — |
| Race (NIH/OMB) White | 37 Participants | 37 Participants | — |
| Region of Enrollment United States | 50 participants | 50 participants | — |
| Sex: Female, Male Female | 50 Participants | 50 Participants | — |
| Sex: Female, Male Male | 0 Participants | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 0 |
| other Total, other adverse events | 0 / 50 | 0 / 0 |
| serious Total, serious adverse events | 0 / 50 | 0 / 0 |
Outcome results
Primary
The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR)
The quantitative measures of standard uptake value (SULpeak and SULmax, prone and supine position) from PET were obtained. SUV = (Tracer activity in tissue)/(Injected radiotracer dose/patient weight or lean body mass) with unit microcuries/g/(millicuries/kg) (no unit after simplification). The SUV was averaged over the tumor regions. These averages were computed for each patient at each time point. All patients were were planned to be scanned three times: prior to treatment, during treatment and at the end of treatment. The change of SUV was calculated as the end of treatment value minus the pre-treatment value. Then the difference in the change between the responders and non-responders were estimated using Wilcoxon rank sum test. The pseudomedians and nonparametric confidence intervals for the difference (change of non-responders minus the change of responders) were reported for parameters SULpeak and SULmax measured for different positions. Pathological response were measured at the
Time frame: up to 6 months (1 scan prior to chemotherapy and 2 scans prior to surgery)
Population: 19 Patients had the scanned data at two time points: prior treatment and at the end of treatment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Fluorodeoxyglucose PET/CT (FDG-PET/CT) | The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR) | Difference in SULpeak change, prone | 1.23 microcuries/g/(millicuries/kg) |
| Fluorodeoxyglucose PET/CT (FDG-PET/CT) | The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR) | Difference in SULmax change, prone | 2.12 microcuries/g/(millicuries/kg) |
| Fluorodeoxyglucose PET/CT (FDG-PET/CT) | The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR) | Difference in SULpeak change, supine | 1.89 microcuries/g/(millicuries/kg) |
| Fluorodeoxyglucose PET/CT (FDG-PET/CT) | The Difference in the Change (Pre and End-treatment) of Standard Uptake Value (SUV) Between Pathological Non-responders and Responders (pCR) | Difference in SULmax change, supine | 2.88 microcuries/g/(millicuries/kg) |
Secondary
Compare and Combine Magnetic Resonance Imaging (MRIs) (Obtained From Study BRE0588) and Positron Emission Tomography/ Computed Tomography (PET/CT) Methods to Develop a Robust Assessment of Tumor Status.
Time frame: 48 months
Population: There were insufficient number of patients who had both MRI and PET performed to allow for meaningful statistical comparisons.