breast cancer carcinoma of the breast
Conditions
Interventions
None listed
Sponsors
Universiteit Twente
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Photoacoustic images will be compared with the outcomes of clinical investigation, conventional imaging, optical properties of healthy and malignant tissue and pathology. In the first stage of the study (3 months, 10 patients), the photoacoustic images will mainly be used to optimize the measurement and analysis methods. In the second stage of the study (18 months 50-70 patients), the images of the BIRADS 4 and 5 lesions will qualitatively be described in order to find photoacoustic markers that are indicative for malignancy and how they are related tot he optical properties of the patients breast tissue. In the third stage of the study (3 months, about 20 patients), which will only be reached if the results of the first two phases are promising, also non-cancerous breast (normal breast tissue and benign lesions - BIRADS 1,2)) will be investigated for the presence of the photoacoustic malignancy markers. | — |
Countries
Netherlands
Outcome results
None listed