Breast Cancer
Conditions
Brief summary
The purpose of this study is: 1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer? 2. To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.
Detailed description
Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.
Interventions
DEVICEPEM Flex Solo II PET Scanner
Subjects will receive bilateral (both sides) breast and axillary PEM scans.
DEVICEMRI scan
Subjects will receive bilateral (both sides) breast and axillary MRI scans.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy)
Exclusion criteria
* Children (\< 18 years old) * Pregnant or Lactating women * Diabetic patients (Type I or II) * Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM * Patients who have NOT undergone a standard of care bilateral breast MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Tumor Size | 1-2 weeks post treatment onset | Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Beast Cancer Subjects Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods
PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.
MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Beast Cancer Subjects |
|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 6.98 |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Reduction in Tumor Size
Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.
Time frame: 1-2 weeks post treatment onset
Population: This study has been terminated due to poor accrual.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Beast Cancer Subjects | Reduction in Tumor Size | PEM tumor size pre chemotherapy | 25.67 mm | Standard Deviation 7.5 |
| Beast Cancer Subjects | Reduction in Tumor Size | PEM tumor size post chemotherapy | 9.67 mm | Standard Deviation 16.7 |