Breast Cancer
Conditions
Brief summary
After locating the suspicious lesion/mass with standard of care mammography and/or ultrasound, a photoacoustic scan will be performed in the breast where the lesion is located. After the PA scan a biopsy will be performed, if clinically indicated (based on the mammogram and ultrasound only).
Interventions
PROCEDUREPhotoacoustic Imaging (PAI)
Standard of Care
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients must have a breast lesion/mass found at physical examination, mammography or ultrasound (US), that has not been surgically resected * Patients may have any of the following characteristics: * Taking hormones (e.g., contraceptives, hormone replacement therapy, post-cancer Tamoxifen) * Breast implants * Previous breast biopsy * Previous breast surgery * Previous breast cancer * High risk of breast cancer (e.g., breast cancer susceptibility gene (BRCA) mutations, other gynecologic cancer) * Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Patients who have had primary surgical excision of the suspicious finding * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The lesion visibility on PAI, described using a five-level scale: 1. Not visible 2. Barely visible 3. Fair (or moderately visible) 4. Visible 5. Clearly visible. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Measures of hypoxia in the lesion | 6 months |
Outcome results
None listed