Early Detection of Breast Cancer Using Tomosynthesis Imaging

Breast Neoplasms Clinical Trial

Official title:

Early Detection of Breast Cancer Using Tomosynthesis Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637598
• Other study ID #: Pro00013552
• Secondary ID: 60246503
• Status: Completed
• Phase: N/A
• First received: March 12, 2008
• Last updated: April 11, 2017
• Start date: November 2004
• Est. completion date: October 2013

Study information

• Verified date: July 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.

Description:

Finding breast cancer early has been shown to improve the chance of survival. Mammography (x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however, are not seen on mammography, which creates two-dimensional images for the radiologist to see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D (three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D information so that they can find breast cancers which might otherwise be hidden from view.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

All Subjects accepted for this clinical study must:

• Be already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy for standard clinical indications

• Provide written informed consent

• Be able to communicate effectively with clinical study personnel.

Exclusion Criteria:

Subjects with any of the following conditions will be excluded from this clinical study:

• Childbearing potential and subject refuses serum pregnancy test or test result is positive.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Radiation:
• Mammography and tomosynthesis imaging
All subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography).

Locations

Country	Name	City	State
United States	DUMC Mammography, Duke South Hospital, 2nd floor	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiologist ROC (receiver operating characteristic) area under curve (AUC)		at imaging review by the end of the study, approximately 9 years