Photo-Acoustic and Ultrasonographic Mammoscope
Recruiting
Phase 2
Interventional Study
Benign Breast Lesions
Malignant Breast Tumours
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 180 (estimated)
- Sponsor
- Franciscus Gasthuis & Vlietland (Hospital) · Other
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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.
Trial Locations
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Eligibility Criteria
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 questionn…
Contacts