A new device (PAMMOTH) for hybrid photoacoustic and ultrasound mammoscopy to evaluate screening-detected abnormalities in the breast

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

Healthy volunteers:
- Adult women;
- Subjects who are fully competent to give informed consent.

Extra criteria for patients:
- Adult women who present at the Centre for Mammacare with an anomaly in the
breast, which, after clinical investigation and diagnostic imaging is suspect
to be of an ICNST, ILC, DCIS, FA or cyst;
- Subjects who are fully competent to give informed consent.

Exclusion Criteria

Healthy volunteers:
- Subjects with a (history of) breast disease;
- Subjects with a tattoo or irremovable piercings on/in the breast;
- Subjects who are pregnant or who are breastfeeding.
- Subjects with a known allergy for PVC
- Subjects who are not physically capable of climbing on the examination bed,
who*s breast are too big to fit in the cup sizes or are not capable to lay
still in prone position for the requested examination time.

Criteria for patients:
- Subjects who had a breast biopsy in the 6 months prior to this study;
- Subjects with bloody discharge, breast ulcers or -wounds;
- Subjects with a history of surgery (including cosmetic surgery) or radiation
therapy on the breast;
- Subjects who are currently undergoing chemotherapy;
- Subjects with a tattoo or irremovable piercings on/in the breast;
- Subjects who are pregnant or who are breastfeeding;
- Subjects with contra-indication for breast MRI. (only in Medisch Spectrum
Twente)
- Subjects with a known allergy for PVC
- Subjects who are not physically capable of climbing on the examination bed,
who*s breast are too big to fit in the cup sizes or are not capable to lay
still in prone position for the requested examination time.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main deliverable is a set of PA/USCT breast images from healthy breasts,<br /><br>breasts containing malignant lesions, breasts containing benign lesions and all<br /><br>contralateral breasts. Furthermore, images acquired using conventional imaging<br /><br>modalities: x-ray and/or US and MRI will be collected in stage 2. For the<br /><br>patients who had to undergo a biopsy, we will also perform extensive pathology<br /><br>investigations as described in the study design. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We ask the radiologists to evaluate the breast density based on the MMG<br /><br>investigation. With this knowledge we can investigate the imaging performance<br /><br>and sensitivity of the PAM3(+) device in breasts with different densities.<br /><br><br /><br>All subjects will be asked to fill out a questionnaire. The questionnaire (F1)<br /><br>can be will contain questions on:<br /><br>• Comfort / burden of the measurement;<br /><br>• Personal information such as age, height, weight, breast size and moment in<br /><br>menstrual cycle at the time of measurement (if applicable).<br /><br>This questionnaire gives us the opportunity to answer the following set of<br /><br>questions:<br /><br>• Does the breast size influence the imaging performance and sensitivity of the<br /><br>PAM3(+) device?<br /><br>• Does the menstrual cycle influence the imaging performance and sensitivity of<br /><br>the PAM3(+) device?<br /><br>Other interesting questions may be defined during the study</p><br>