Dedicated Breast CT for Diagnosis of Breast Cancer.

Completed

Conditions: Breast cancer
Mamma carcinoma
10006291

Registration Number: NL-OMON52995

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 210

Inclusion Criteria

- Women age 35 or older
- Women scheduled to undergo a diagnostic work-up following an abnormal
screening mammogram (BI-RADS 0) with the suspicious finding NOT located in the
axillary tail of the breast.
- Women who underwent diagnostic work-up following an abnormal screening
mammogram and were assigned a BI-RADS 4 or 5 due to soft tissue lesions, or due
to microcalcifications with the suspicious finding NOT located in the axillary
tail of the breast.

Exclusion Criteria

- Women who do not meet the inclusion criteria
- Women with suspected or confirmed pregnancy
- Women who have had bilateral mastectomy
- Women whose suspicious lesion is located in the axillary tail
- Women with prior breast cancer or breast biopsy in the recalled breast in the
last 12 months
- Women with palpable lesions
- Women who are breastfeeding
- Women who are very frail and unable to cooperate
- Women who cannot give informed consent
- Male subjects

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Difference in ROC area under the curve of breast CT vs. standard work-up for<br /><br>diagnosis of breast cancer.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Sub-analysis for difference in ROC area under the curve of breast CT vs.<br /><br>standard work-up for diagnosis of breast cancer divided by type of lesion.</p><br>