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Recruiting NCT07492589

Photo-Acoustic and Ultrasonographic Mammoscope

Phase II Interventional Benign Breast Lesions Malignant Breast Tumours

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Photo-Acoustic Mammoscope Imager 3+.
Who it may be relevant to
Registry conditions: Benign Breast Lesions, Malignant Breast Tumours. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Photo-Acoustic and Ultrasound MammoScope to Detect Breast Lesions: The PAUS Study

Overview

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.

Detailed 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.

Interventions

  • Device Photo-Acoustic Mammoscope Imager 3+
    Patients 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 t

Primary outcome measures

  • PAM3+ performance [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (12)
  • Sensitivity [Time frame: through study completion, an average of 1 year]
  • Positive predictive value [Time frame: through study completion, an average of 1 year]
  • Specificity of the PAM3+ [Time frame: through study completion, an average of 1 year]
  • Differences in Performance [Time frame: through study completion, an average of 1 year]
  • Accuracy [Time frame: through study completion, an average of 1 year]
  • Mammary gland visibility [Time frame: through study completion, an average of 1 year]
  • Agreement [Time frame: through study completion, an average of 1 year]
  • Agreement [Time frame: through study completion, an average of 1 year]
  • Patient Satisfaction [Time frame: Periprocedural]
  • System usability score [Time frame: Periprocedural]
  • Agreement Between BI-RADS Categories Assigned by Breast Radiologists Using Conventional Imaging vs. PAM3+ 3D Imaging [Time frame: through study completion, an average of 1 year]
  • Adverse events [Time frame: Periprocedural]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 1 center
  • Franciscus Vlietland Ziekenhuis — Schiedam

Identifiers

NCT: NCT07492589 · NL-010685

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗