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

Completed

• Conditions: Breast Cancer
• Interventions: Device: Genesis and Gemini; Device: Investigational 3D Mammography system

• Registration Number: NCT00759447
• Lead Sponsor: Hologic, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-24
• Study First Posted: 2008-09-25
• Status Verified: 2015-03
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 240

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3D Imaging with commercial Mammography Device	Genesis and Gemini	-
3D investigational imaging	Investigational 3D Mammography system	Patients enrolled will be imaged with a 3D mammogram in one of 3 speeds of acquisition

Primary Outcome Measures

Name	Time	Method
Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design	1 year	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