MedPath

Visualization of breast cancer with the first generation photoacoustic mammoscope

Completed
Conditions
breast cancer
carcinoma of the breast
10006291
Registration Number
NL-OMON39181
Lead Sponsor
niversiteit Twente
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
73
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.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath