Combined tomosynthesis and ultrasound breast imaging

Combined tomosynthesis and ultrasound breast imaging - CT-USBI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51529

Enrollment

Registered

2022-08-03

Start date

2022-11-25

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult woman (18 years or older) Referred for a breast exam (Radboudumc, Nijmegen) because of o or referral by GP or specialist, o or referral by Dutch National Screening Program, o or periodic breast screening. Suspicious lesion based on referral or previous breast exams. DBT image is obtained as part of the regular breast exam.

Exclusion criteria

Exclusion criteria: - Pregnant - Lactating - Experienced previous mammography/DBT exams as painful.

Design outcomes

Primary

Measure	Time frame
The main study endpoints are the acquired images (ultrafast and conventional ultrasound, DBT) and their image quality scores. The images will be scored by at least two experienced radiologists in reading volumetric ultrasound and DBT images. The scoring criteria are similar as in [1]. The breast density, lesion type, biopsy results and Breast Imaging RADiology score (BI-RADS) are used to interpret the images and the obtained results. [1] B. Schaefgen et al., "First proof-of-concept evaluation of the FUSION-X-US-II prototype for the performance of automated breast ultrasound in healthy volunteers," (in eng), Archives of gynecology and obstetrics, vol. 304, no. 2, pp. 559-566, 2021.	—

Measure

Time frame

The main study endpoints are the acquired images (ultrafast and conventional ultrasound, DBT) and their image quality scores. The images will be scored by at least two experienced radiologists in reading volumetric ultrasound and DBT images. The scoring criteria are similar as in [1]. The breast density, lesion type, biopsy results and Breast Imaging RADiology score (BI-RADS) are used to interpret the images and the obtained results. [1] B. Schaefgen et al., "First proof-of-concept evaluation of the FUSION-X-US-II prototype for the performance of automated breast ultrasound in healthy volunteers," (in eng), Archives of gynecology and obstetrics, vol. 304, no. 2, pp. 559-566, 2021.

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Countries

Netherlands

Outcome results