Imaging of the breast using light and sound

Recruitment & Eligibility

Status: Other

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

Adult women who come to the mammapoli with a lesion suspicious for malignancy, which, after clinical investigation and diagnostic imaging is classified as BIRADS 4 or 5, or BIRADS 2 or 3;
- Subjects who are fully competent to give informed consent.

For healthy volunteer measurements:
- Adult women;
- Subjects who are fully competent to give informed consent.

Exclusion Criteria

- Subjects who have a cup size of D or larger OR subjects for whom the biggest size breast supporting cup is too small;
- Subjects who had a breast biopsy in the 6 months prior to this study;
- Subjects with bloody discharge, ulcers or wounds on the breast;
- Subjects with a history of surgery (including cosmetic surgery) or radiation
therapy on the breast;
- Subjects who are currently undergoing chemotherapy.

For healthy volunteer measurements:
- Subjects who have a cup size of D or larger OR subjects for whom the biggest size breast supporting cup is too small;
- Subjects who have symptoms of breast cancer such as a palpable mass which
might be attributed to breast cancer;
- Subjects who have had (a) benign breast lesion(s) in the past;
- Subjects who have had breast cancer in the past;
- Subjects who had a breast biopsy in the 6 months prior to this study;
- Subjects with blood discharge, ulcers or wounds on the breast;
- Subjects with a history of surgery (including cosmetic surgery) or radiation
therapy on the breast;
- Subjects who are currently undergoing chemotherapy.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main study parameter is a set of photoacoustic breast images from healthy breasts, breasts containing malignant lesions and breasts containing benign lesions. Images from the subjects’ breasts taken with conventional imaging modalities are collected (x-ray, ultrasound, MRI, pathology). The main objective is to investigate the feasibility of PAM 2 in breast cancer imaging, characterizing the photoacoustic appearances of different types of malignant and benign lesions. The photoacoustic images are described qualitatively.

Secondary Outcome Measures

Name	Time	Method
All subjects are asked to fill out a questionnaire. The questionnaire contains questions on experience with measurement (comfort, burden) and personal questions about for example age, height and medical history.