on-invasive screening of the breast with the DELSENI with the DMS method.

Completed

• Conditions: breast cancer; Mamma carcinoma; 10006291

• Registration Number: NL-OMON46469
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- women 18 years and over;
- signed informed consent;
- planned ultrasound for clinical evaluation of palpable or mammographic abnormality in the breast;
- physical and mental condition sufficient to undergo and complete examination.

Exclusion Criteria

- histologically confirmed malignant or pre-malignant abnormality in the breast before participation in this study;
- status after major breast surgery;
- breast biopsy in the last 6 weeks before scan with the DELSENI;
- local inflammation of the breast (including ulcer, abces, etc);
- chemotherapy in the last 5 years before participation;
- no permission for reporting of incidental findings;
- any mental state which prohibits giving informed consent;
- any medical condition which prohibits safe or responsible participation of the subject or subject physically not able to undergo an extra scan

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Improvement of the mathematical algorithm for image reconstruction of the<br /><br>DELSENI device.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable.</p><br>