Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

Breast Neoplasms Clinical Trial

Official title:

Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02771444
• Other study ID #: DOC-EMOA-A7UDZ2
• Status: Terminated
• Phase: N/A
• First received: May 10, 2016
• Last updated: March 22, 2018
• Start date: December 2016
• Est. completion date: March 22, 2018

Study information

• Verified date: January 2018
• Source: Philips Digital Mammography Sweden AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: March 22, 2018
• Est. primary completion date: March 22, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Device:
• Tomo Assessment
A four-view tomosynthesis examination

Locations

Country	Name	City	State
Italy	Ospedale San Rafaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Philips Digital Mammography Sweden AB

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	X-ray dose	X-ray dose will be measured per projection.	4 months
Secondary	Lesion conspicuity comparison of images from study device vs comparator	Lesion conspicuity will be assessed by image readers (radiologists) comparing the conspicuity of the same lesion imaged with the study device to the comparator	4 months