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

Hologic

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Genesis and Gemini; Device: Investigational 3D Mammography system

Study type: Observational

Funder types: Industry

Identifiers

NCT00759447

06-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 240 patients

Sex: Female

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

240 participants in 2 patient groups

3D investigational imaging

Description:

Patients enrolled will be imaged with a 3D mammogram in one of 3 speeds of acquisition

Treatment:

Device: Investigational 3D Mammography system

3D Imaging with commercial Mammography Device

Treatment:

Device: Genesis and Gemini