Photo-Acoustic and Ultrasonographic Mammoscope (PAUS)

Franciscus Gasthuis & Vlietland (Hospital)

Status and phase: Enrolling; Phase 2

Conditions: Malignant Breast Tumours; Benign Breast Lesions

Treatments: Device: Photo-Acoustic Mammoscope Imager 3+

Study type: Interventional

Funder types: Other

Identifiers

NCT07492589

NL-010685

Details and patient eligibility

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.

Full description

Secondary, the diagnostic accuracy of the PAM3+ in the localization, and sizing breast lesions in relation to BI-RADS score, breast density, and conventional imaging is evaluated. This includes assessing usability, patient satisfaction, safety, and establishing the foundation for a PAM3+ lexicon.

Enrollment: 180 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women
2. Age > 18 years
3. Referred to the outpatient breast clinic of the Franciscus Vlietland Hospital due to a possible breast lesion
4. Patients who are fully competent to give written informed consent
5. Sufficient knowledge of the Dutch language to complete a questionnaire

Exclusion criteria

1. Currently undergoing chemotherapy
2. Discharge from the nipple(s)
3. Breast ulcers or -wounds
4. Currently suffering from mastitis
5. Carrier of a resistant bacterium (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or Multidrug resistant organisms (MDRO; in Dutch: BRMO)
6. Irremovable piercings on/in the breast
7. Pregnancy
8. Patients whose breasts do not fit in the cup sizes (small breasts can be measured without a cup)
9. 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
10. A history of photosensitive disease (e.g. porphyria, lupus erythematosus)
11. Currently undergoing therapy for a photosensitive disease and experiencing photosensitive disease
12. Currently undergoing phototherapy
13. Patients with a known allergy for PVC
14. Patients that are not physically capable of climbing on the examination bed
15. Patients that are not physically capable of laying on the examination bed during the measurements

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

All patients

Experimental group

Description:

All patients included in this study will undergo measurements with the PAM3+ imager.

Treatment:

Device: Photo-Acoustic Mammoscope Imager 3+