Breast imaging using light and sound.
Recruiting
- Conditions
- Breast cancer
- Registration Number
- NL-OMON26509
- Lead Sponsor
- Prof. dr. ir. Wiendelt SteenbergenOn behalf of Biomedical Photonic Imaging, University of Twente
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1. Adult women, who come to the Centre for Mammacare with a lesion suspicious for malignancy that, after clinical investigation and anamnesis is classified as a BIRADS IV or V (Phase 1,2) or a BIRADS I or II (phase 3) lesion. In addition, the lesion or suspect must have been deemed as being manifestable in a photoacoustic examination;
2. Patients in good general health that allows them to undergo the examination in a prone position for a period of 45 minutes;
Exclusion Criteria
1. Patients whose physical condition is expected to be insufficient for mounting the examination bed and staying on this bed for 45 minutes without too much discomfort;
2. Patients who had a breast biopsy in 3 months prior to this study;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Photoacoustic images will be compared with the outcomes of clinical investigation, conventional imaging and pathology. In the first stage of the study, the photoacoustic images will mainly be used to optimize the measurement and analysis methods. In the second phase of the study, the images of the BIRADS IV and V lesions will qualitatively be described in order to find photoacoustic markers that are indicative for malignancy. In the third stage of the study, which will have a certain overlap with phase 2, also non-cancerous breast will be investigated for the presence or absence of the photoacoustic malignancy markers.
- Secondary Outcome Measures
Name Time Method