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

niversity of Twente0 sites60 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Observational non invasive

Sponsor

niversity of Twente

•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.

•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;