Photoacoustic Imaging (PAI) of Suspicious Breast Cancers - A Clinical Feasibility Study
Not Applicable
Withdrawn
- Conditions
- Breast Cancer
- Registration Number
- NCT01780532
- Lead Sponsor
- Stanford University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Measures of hypoxia in the lesion 6 months