Breast Cancer, Indeterminate but likely benign breast anomalies, benign breast anomalies Breast Cancer, Benign breast lesions
Conditions
Interventions
The PAM3+ is a static medical device that uses photoacoustics combined with ultrasonographic computed tomography (PA-USCT). The PAM3+ contains an aperture to which the right size plastic cup is attach
Sponsors
Franciscus
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Women Age 18 or above Referred to the outpatient breast clinic of the Franciscus Vlietland Hospital due to a possible breast abnormality Patients who are fully competent to give written informed consent Sufficient knowledge of the Dutch language to complete a questionnaire
Exclusion criteria
Exclusion criteria: Breast biopsy in the 6 months prior to study examination Currently undergoing chemotherapy Discharge from the nipple(s) Breast ulcers or -wounds Currently suffering from mastitis Currently carrier of multiresistant bacterium (e.g MRSA or MRDO) Irremovable piercings on/in the breast Pregnancy or breastfeeding Patients whose breasts do not fit in the cup sizes (small breasts can be measured without a cup) Currently using medication that increases photo-toxicity of the skin or skin care products that increase photosensitivity (e.g. certain antibiotics: tetracyclines or quinolones, certain antidiuretics A history of photosensitive disease (e.g. porphyria, lupus erythematosus) Currently undergoing therapy for a photosensitive disease and experiencing photosensitive disease Currently undergoing phototherapy Patients with a known allergy for PVC Patients that are not physically capable of climbing on the examination bed Patients that are not physically capable of laying on the examination bed for the duration of the measurements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the negative predictive value of the PAM3+ in the detection of breast lesions. For this explorative study, the primary outcome measure is the negative predictive value (NPV) of PAM3+, with conventional imaging as reference (defined as Bi-RADS scores 4-5 vs. Bi-RADS scores 2-3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints are: The sensitivity of the PAM3+ to detect breast lesions The positive predictive value of the PAM3+ to detect breast lesions The specificity of the PAM3+ for malignant (Bi-RADS 5) lesions Differences in negative predictive value per Bi-RADS scores (2-6) The proportion in which the PAM3+ device is able to visualize the entire mammary gland, confirmed by visibility of the pectoral muscle. The agreement in performance of PAM3+ and conventional imaging for each Bi-RADS scores (0-5) and each breast density category The agreement between PAM3+ tumor size and conventional imaging and histopathological results The agreement between PAM3+ tumor location and conventional imaging and histopathological results The agreement between PAM3+ and conventional imaging and histopathological results for different types of breast lesions (e.g. fibroadenoma, DCIS, cysts) Patient satisfaction using the patient satisfaction questionnaire directly after PAM3+ measurement System usability measured using the system usability questionnaire directly after PAM3+ measurement The rate of any adverse events | — |
Countries
Netherlands
Contacts
Public ContactL Riks
Franciscus
Outcome results
None listed