Breast Cancer
Conditions
Keywords
Breast cancer
Brief summary
This study is a feasibility study to determine if a combined breast PET/CT scanner can image malignant functional activity while determining anatomical structure in the same clinical setting for patients with breast cancer. End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device. The secondary purpose of this study is to explore protocol parameters with a view to optimizing imaging performance whilst minimizing patient discomfort. Imaging results will be compared to histological samples to determine ground truth.
Detailed description
PET is literally a molecular imaging modality. In monitoring the patient's response to a specific chemotherapeutic regime, baseline and subsequent PET/CT scans can be used to quantitatively determine the therapeutic effect of the regime, using the standard uptake value (SUV), a common metric in PET imaging. The breast PET/CT system will facilitate molecular imaging of breast cancer using a number of radiolabeled molecules, available both commercially (18-FDG) and from the research environment.
Interventions
Positron emission tomography and computed tomography
Sponsors
University of California, Davis
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
Yes
Inclusion criteria
\- Normal Adult Volunteers * Female, at least 18 years of age * Ability to lie motionless for up to 20 minutes Patient Volunteers * Female, at least 18 years of age * Diagnostic findings from prior mammography highly suggestive of invasive breast carcinoma (BI-RADS category 5) * Not pregnant or breast-feeding * Ability to lie motionless for up to 20 minutes
Exclusion criteria
* Normal Adult Volunteers * Inability to understand the risks and benefits of the study Patient Volunteers * Recent breast biopsy * Diagnostic findings from prior mammography highly suggestive of noninvasive ductal or lobular carcinoma * Uncontrolled diabetes * Diabetic and blood sugar level \> 200 mg/dL * Positive urine pregnancy test or currently breast-feeding * Inability to understand the risks and benefits of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device. | 5 years |
Countries
United States
Outcome results
None listed