A Pilot Study - Comparison of Two Hologic 3D Mammography Systems

Breast Cancer Clinical Trial

Official title:

A Multicenter Pilot Study to Evaluate the Image Quality of Two Hologic Tomosynthesis Mammography Systems

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759447
• Other study ID #: 06-01
• Status: Completed
• Start date: December 2007
• Est. completion date: September 2008

Study information

• Verified date: March 2015
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study to compare the prototype tomosynthesis mammography system to the tomosynthesis system slated for commercial release.

Description:

A perspective non randomized, noncontrolled, multicenter pilot study enrolling a minimum of 60 female subjects. The purpose of the pilot study is to compare the images acquired from two Hologic tomosynthesis systems. Information obtained from the study will be used to determine endpoints for a future larger study. Study participants are enrolled in one of three groups, the group in which they are enrolled wil determine which tomosynthesis system images will be acquired upon.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Female, any ethnic origin

• No contraindication for diagnostic mammography

Exclusion Criteria:

• Any contraindications to mammographic imaging including but not limited to significant existing breast trauma, pregnancy, lactating, breast implants.

• Under 30 years of age at the time of consent

• Unable to understand and execute written informed consent

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Genesis and Gemini
3 dimensional breast mammography system
• Investigational 3D Mammography system
3 dimensional breast mammography system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design	images are acquired on 2 systems with different speeds of time and reviewed compared to 2D images. Subjects are enrolled in one group or another and are diagnostic patients returning for addition work up on an area of interest	1 year