NL-OMON39181
Completed
Not Applicable
Visualization of breast cancer with the first generation photoacoustic mammoscope - photoacoustic mammography
niversiteit Twente0 sites73 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- breast cancer
- Sponsor
- niversiteit Twente
- Enrollment
- 73
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Photoacoustic part:
- •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 3\-5 (phase 1 and 2\) or a BIRADS 1 or 2 (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;
- •3\) Patients who are fully competent to give informed consent.;DPS part:
- •1\) all inclusion criteria for photoacoustic imaging;
- •2\) patient who gave informed consent for the photoacoustic imaging study;
- •3\) patient who will have a ultrasound\-guided breast biopsy to investigate the lesion, which should be accessible with the VACORA biopsy system.
Exclusion Criteria
- •Photoacoustic part:
- •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;
- •3\) Patients with bloody discharge, ulcers or wounds on the breast;
- •4\) Patients with a history of surgery or radiation therapy on the breast;
- •5\) Patients who are currently undergoing chemotherapy.;DPS part
- •1\) all under 'photoacoustic part'
- •2\) patient who don't gave informed consent for the photoacoustic part
- •3\) patient who use anticoagulantia;
- •4\) patients from which the lesion is inaccessible with the VACORA biopsy needle.
Outcomes
Primary Outcomes
Not specified
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