This trial is active, not recruiting.

Conditions breast cancer, mass cystic, benign mass
Treatment tomosynthesis and ultrasound imaging
Sponsor University of Michigan
Collaborator National Institutes of Health (NIH)
Start date April 2002
End date December 2014
Trial size 260 participants
Trial identifier NCT00721435, HUM00045519 (2002-0584)


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Evaluating a non-invasive breast screening and diagnostic device, 3D tomosynthesis and 3D ultrasound. Evaluate the utility of adding ultrasound.
tomosynthesis and ultrasound imaging
3D and ultrasound imaging for breast abnormalities and masses

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 determned later.

Eligibility Criteria

Female participants at least 25 years old.

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

Additional Information

Official title Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions
Principal investigator Paul L Carson, PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Michigan.