Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography

A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 2. Women Undergoing Diagnostic Mammography

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00535327

Enrollment

220

Registered

2007-09-26

Start date

2007-08-31

Completion date

2010-03-31

Last updated

2010-05-14

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

Conditions

Breast Cancer

Keywords

Mammography, mammogram, breast, Abnormal and normal breast tissue

Brief summary

Comparison of the ability of DBT and FFDM to detect breast cancer.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Women ≥18 years or older and has underwent screening mammography and is now referred for diagnostic mammography * Able and willing to comply with study procedures, and have signed and dated the informed consent form * Surgically sterile or postmenopausal

Exclusion criteria

* Pregnant or trying to become pregnant * Has signs or symptoms of breast cancer * Has been previously included in this study * Has breast implants * Has a history of breast cancer and is in active treatment * Has breasts too large to be adequately positioned for the DBT examination

Outcome results