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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00721435
• Other study ID #: HUM00045519 (2002-0584)
• Secondary ID: R01CA091713
• Status: Completed
• Phase: N/A
• First received: July 22, 2008
• Last updated: January 22, 2017
• Start date: April 2002
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: October 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Mass
• Breast Cancer
• Mass Cystic

Intervention

Procedure:
• 3D Tomosynthesis and ultrasound imaging
3D tomosynthesis & ultrasound imaging for scanning masses or healthy breast tissue

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.