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Optimal contact-pressure for Digital Breast Tomosynthesis

Optimal contact-pressure for Digital Breast Tomosynthesis - Optimal pressure for DBT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49000
Enrollment
935
Registered
2018-02-28
Start date
2018-12-03
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

One of the DBT-recordings per included breast is replaced by a custom *two- in-one* DBT-recording. Instead of releasing the breast immediately after the x-ray exposure, the mammography technologist w

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. female 2. older than 30 years of age 3. receives DBT as standard procedure or as indicated by the responsible radiologist on site

Exclusion criteria

Exclusion criteria: 1. unable to understand the patient information folder 2. has or previously had breast endo-prostheses (implants);as breast treatment grouping criterion: underwent any form of breast surgery or therapy, with the exception of Breast Conserving Therapy with radiotherapy

Design outcomes

Primary

MeasureTime frame
We study the influence of the level of contact-pressure on three parameters: lesion conspicuity, absorbed glandular dose and pain experience. The primary analysis consist of two balanced one-way ANOVA tests, one for untreated and one for BCT-treated breasts. From this we determine whether one of the five levels of contact-pressure is significantly optimal for DBT.

Secondary

MeasureTime frame
The secondary objective is to assess the diagnostic value of compression-blinking and x-ray elastography. The research questions for this objective are radiologists* opinions on whether: - these techniques improve the diagnosis (sensitivity, specificity) - they reduce the need for follow-up diagnosis (ultrasound, biopsy) - they are easy to integrate in the workflow (time needed) - they are intuitive to interpret

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)