Dedicated Breast CT for Diagnosis of Breast Cancer.

Dedicated Breast CT for Diagnosis of Breast Cancer. - Breast CT.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52995

Enrollment

340

Registered

2016-01-20

Start date

2016-10-21

Completion date

Unknown

Last updated

2024-04-23

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 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

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

Design outcomes

Primary

Measure	Time frame
Difference in ROC area under the curve of breast CT vs. standard work-up for diagnosis of breast cancer.	—

Secondary

Measure	Time frame
Sub-analysis for difference in ROC area under the curve of breast CT vs. standard work-up for diagnosis of breast cancer divided by type of lesion.	—

Countries

Netherlands

Outcome results