Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

March 22, 2018 updated by: Philips Digital Mammography Sweden AB
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy
        • Ospedale San Rafaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tomo Assessment
Subjects will have a 4-view tomosynthesis examination with the study device.
Device: Tomo Assessment
A four-view tomosynthesis examination
Other Names:
  • MicroDose Tomosynthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
X-ray dose
Time Frame: 4 months
X-ray dose will be measured per projection.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lesion conspicuity comparison of images from study device vs comparator
Time Frame: 4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Digital Mammography Sweden AB

Investigators

  • Principal Investigator: Pietro Panizza, M.D, Ospedale San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

March 22, 2018

Study Completion (Actual)

March 22, 2018

Study Registration Dates

First Submitted

May 10, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 13, 2016

Study Record Updates

Last Update Posted (Actual)

March 26, 2018

Last Update Submitted That Met QC Criteria

March 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOC-EMOA-A7UDZ2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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