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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

30 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genesis and Gemini

Device

3 dimensional breast mammography system

Other names: Selenia Dimensions

Investigational 3D Mammography system

Device

3 dimensional breast mammography system

Primary outcomes

Pilot study- To Evaluate the images acquired on 2 prototype systems for a larger study design

Time frame: 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

Sponsors and collaborators

Lead sponsor

Hologic, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Sep 25, 2008
Registry last updated: Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed