Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

Philips

Status: Terminated

Conditions: Breast Neoplasms

Treatments: Device: Tomo Assessment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02771444

DOC-EMOA-A7UDZ2

Details and patient eligibility

About

This study aims to evaluate image quality of a low-dose tomosynthesis system versus a comparator. Subjects will undergo a four-view tomosynthesis examination with the comparator and with the study device, and images will be assessed by several radiologists by comparing details in the images from the two systems.

Full description

Tomosynthesis is a relatively new technology to acquire mammographic images where images are acquired over several projection angles, giving 3d information that can help radiologists assess images.

The aim of the study is to see whether a new low-dose tomosynthesis system has comparable image quality at a lower x-ray radiation dose to a comparator.

Enrollment: 17 patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Woman over 40 years of age
• Has a tomosynthesis examination with comparator
• Has a mammographic finding

Exclusion criteria

• Pregnant, breastfeeding or believes she may be pregnant
• Unable or unwilling to give informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Tomo Assessment

Experimental group

Description:

Subjects will have a 4-view tomosynthesis examination with the study device.

Treatment:

Device: Tomo Assessment