Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00721435

Enrollment

183

Registered

2008-07-24

Start date

2002-04-30

Completion date

2016-10-31

Last updated

2017-01-24

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

Conditions

Benign Mass, Breast Cancer, Mass Cystic

Brief summary

The study will evaluate and refine a breast screening and diagnosis device.

Detailed description

The device produces 3-D mammograms and ultrasound pictures of the breast at the same time and in the same position. This should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. The 3-D mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy.

Interventions

PROCEDURE3D Tomosynthesis and ultrasound imaging

3D tomosynthesis & ultrasound imaging for scanning masses or healthy breast tissue

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* To participate in this research study you must be a female over the age of 25 * Have had a normal mammogram or are scheduled for a breast biopsy * Have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy.

Exclusion criteria

* Male * Under the age of 25 * Documented breast cancer

Design outcomes

Primary

Measure	Time frame
To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position.	To be determined later.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026