Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT07492589

Photo-Acoustic and Ultrasonographic Mammoscope

Led by Franciscus Gasthuis & Vlietland (Hospital) · Updated on 2026-03-25

180

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Photo-Acoustic and Ultrasonographic Mammoscope

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women
  • Age greater than 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
Not Eligible

You will not qualify if you...

  • Currently undergoing chemotherapy
  • Discharge from the nipple(s)
  • Breast ulcers or wounds
  • Currently suffering from mastitis
  • Carrier of a resistant bacterium (e.g. MRSA or MDRO)
  • Irremovable piercings on or 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 or skin care products that increase photosensitivity (e.g. certain antibiotics or antidiuretics)
  • History of photosensitive disease (e.g. porphyria, lupus erythematosus)
  • Currently undergoing therapy for a photosensitive disease and experiencing symptoms
  • Currently undergoing phototherapy
  • Known allergy to PVC
  • Not physically capable of climbing on the examination bed
  • Not physically capable of laying on the examination bed during measurements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Franciscus Vlietland Ziekenhuis

Schiedam, South Holland, Netherlands, 3118 JH

Actively Recruiting

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Research Team

L

Linda Riks, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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Photo-Acoustic and Ultrasonographic Mammoscope | DecenTrialz