Digital Breast Tomosynthesis in Younger Symptomatic Women

Digital Breast Tomosynthesis (DBT): Sensitivity for Cancer and Accuracy in Assessing Extent of Malignant Disease in Symptomatic Women Below 60 With Clinical or Ultrasound Signs Compatible With Malignancy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01241981

Enrollment

446

Registered

2010-11-16

Start date

2011-03-31

Completion date

2018-02-28

Last updated

2018-05-08

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

Conditions

Breast Cancer

Keywords

Breast, Cancer, Digital, Mammography, Tomosynthesis

Brief summary

This study will examine a new imaging technique called digital breast tomosynthesis (DBT) compared to standard mammography in women under 60 presenting with signs of breast cancer. The reason that we need to do this study is that standard mammography fails to detect the cancer in approximately 20% of these women because younger women have denser breast tissue. We hope that DBT will be more sensitive in detecting breast cancer than standard mammography.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 59 Years

Healthy volunteers

Inclusion criteria

* Female * Under 60 years old * Clinical or ultrasound suspicion of breast cancer

Exclusion criteria

* Unable to give informed consent * Male * Obvious advanced breast cancer * Obvious medical problems meaning surgery would not be an option

Design outcomes

Primary

Measure	Time frame
Sensitivity of DBT for breast cancer, compared with FFDM	Two years

Secondary

Measure	Time frame
Accuracy of DBT compared with FFDM in assessment of tumour extent	Two years
Relative accuracy of DBT and FFDM by breast density	Two years

Countries

United Kingdom

Outcome results