Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

Breast Cancer Clinical Trial

Official title:

Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01669148
• Other study ID #: 2007p-001197
• Status: Active, not recruiting
• Phase: N/A
• First received: April 30, 2010
• Last updated: August 16, 2012
• Start date: November 2007
• Est. completion date: October 2012

Study information

• Verified date: August 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary hypothesis to be tested is:

Detection of breast cancer will be increased with tomosynthesis (3D) imaging.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Female

• Any ethnic origin

• No contraindication for routine bilateral mammography

Exclusion Criteria:

Potential subjects with any of the following will not be enrolled in the study:

• Any contraindications to mammographic screening, including, but not limited to:

• Significant existing breast trauma

• Under the age of 30 at the time of consent

• Breast Implants

• Prior Surgeries

• Unable to understand and execute written informed consent

• Pregnant

• Lactating

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Tomosynthesis
The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).
• standard mammography

Locations

Country	Name	City	State
United States	MGH	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	image quality	image quality with standard mammography vs tomosynthesis	concurrent assessment of image quality with up to two year follow up for development of breast cancer	No