Photo-Acoustic and Ultrasonographic Mammoscope
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFranciscus Gasthuis & Vlietland (Hospital)
About this trial
The aim of this study is to evaluate the negative predictive value of the Photo Acoustic Imager 3+ (PAM3+) in the detection of female breast lesions (malignant and benign)in an outpatient setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women
Age > 18 years
Referred to the outpatient breast clinic of the Franciscus Vlietland Hospital due to a possible breast lesion
Patients who are fully competent to give written informed consent
Disqualifiers
Currently undergoing chemotherapy
Discharge from the nipple(s)
Breast ulcers or -wounds
Currently suffering from mastitis
Trial design
Design model
Single group
Treatments tested in this trial
Photo-Acoustic Mammoscope Imager 3+
DevicePatients will lay in prone position on the PAM3+ with one breast at a time in the aperture of the machine. The breast is supported by a plastic cup that holds the breast in place. The aperture/bowl is filled with water. During the measurement, infrared light will be emitted onto the breast. Infrared light will be absorpted by red blood cells which results in contrast compared to its surroundings and it will cause minuscule movements in the surrounding water. These movements will be detected by the ultrasound detectors. The movements and the absorption together will create a 3D image of the breast.
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: All patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
PAM3+ performance
To evaluate the performance of the PAM3+ system in breast imaging. Performance is defined as the negative predictive value in the detection of breast lesions (malignant and benign).
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Sensitivity
To determine the sensitivity of the PAM3+ to detect breast lesions
Time frame
through study completion, an average of 1 year2
Positive predictive value
To determine the positive predictive value of the PAM3+ in the detection of breast lesions
Time frame
through study completion, an average of 1 year3
Specificity of the PAM3+
To determine the specificity of the PAM3+ for malignant lesions (e.g. malignant biopsy)
Time frame
through study completion, an average of 1 year4
Differences in Performance
To identify differences in performance per Breast Imaging-Reporting and Data System (Bi-RADS) scores (2-5). It ranks 2 (benign) to 5 (malignant). A higher score means a higher chance of breast cancer.
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov