Combined tomosynthesis and ultrasound breast imaging

Completed

• Conditions: breast cancer; lesion; 10006232

• Registration Number: NL-OMON51529
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

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

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

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

Study & Design

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>