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

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

Completed

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Key information

Conditions

Breast Cancer Benign Mass Breast Diseases Breast Neoplasms Mass Cystic Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D Tomosynthesis and ultrasound imaging

Procedure

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

Primary outcomes

To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position.

Time frame: To be determined later.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2002
Primary completion: 2014
Study completion: 2016
First posted: Jul 24, 2008
Registry last updated: Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed