Photo-Acoustic and Ultrasonographic Mammoscope
Recruiting · NCT07492589 · Interventional (participants receive a specific treatment) · Lead sponsor: Franciscus Gasthuis & Vlietland (Hospital)
View the official record on ClinicalTrials.gov →Interventions studied
Photo-Acoustic Mammoscope Imager 3+
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- Sufficient knowledge of the Dutch language to complete a questionnaire
Exclusion criteria
- Currently undergoing chemotherapy
- Discharge from the nipple(s)
- Breast ulcers or -wounds
- Currently suffering from mastitis
- Carrier of a resistant bacterium (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or Multidrug resistant organisms (MDRO; in Dutch: BRMO)
- Irremovable piercings on/in the breast
- Pregnancy
- 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 during the measurements
Where it is running
1 location listed.
- Franciscus Vlietland Ziekenhuis - Schiedam, South Holland, Netherlands