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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46469

Enrollment

Registered

2018-02-22

Start date

2018-04-05

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer Mamma carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Improvement of the mathematical algorithm for image reconstruction of the DELSENI device.	—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results