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Digital breast tomosynthesis in screening younger higher risk women

A randomised trial of screening with digital breast tomosynthesis plus conventional digital 2D mammography versus 2D mammography alone in women aged 40 to 49 at increased risk of breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37806452
Enrollment
2904
Registered
2014-04-03
Start date
2014-04-01
Completion date
Unknown
Last updated
2021-05-03

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

Conditions

Topic: Cancer

Interventions

Participants who have not had a screening mammogram before will have a standard 2D mammogram and DBT. Women who have undergone screening mammography prior to entering the trial will b

Sponsors

University Hospital of South Manchester (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women aged 40 to 49 years inclusive with an increased risk of breast cancer by virtue of their family history and who have been referred for screening by a family history or genetics service. (Note some women will be aged 50 when they have their second screen within the study) Target Gender: Female; Upper Age Limit 50 years ; Lower Age Limit 40 years

Exclusion criteria

Exclusion criteria: 1. Inability to give informed consent, including inability to understand the nature and purpose of the study 2. Breast implants 3. Pregnancy 4. Previous breast cancer

Design outcomes

Primary

MeasureTime frame
Recall to assessment rate; Timepoint(s): At screening

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026