Working... Menu

Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02771444
Recruitment Status : Terminated (Decision by sponsor, development stopped.)
First Posted : May 13, 2016
Last Update Posted : March 26, 2018
Information provided by (Responsible Party):
Philips Digital Mammography Sweden AB

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Device: Tomo Assessment Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: This is an imaging study. All participants will be imaged using two modalities. All participant data will be deidentified.
Primary Purpose: Diagnostic
Official Title: Low Dose Tomosynthesis Compared to Traditional Tomosynthesis
Actual Study Start Date : December 2016
Actual Primary Completion Date : March 22, 2018
Actual Study Completion Date : March 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

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 Name: MicroDose Tomosynthesis

Primary Outcome Measures :
  1. X-ray dose [ Time Frame: 4 months ]
    X-ray dose will be measured per projection.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02771444

Layout table for location information
Ospedale San Rafaele
Milan, Italy
Sponsors and Collaborators
Philips Digital Mammography Sweden AB
Layout table for investigator information
Principal Investigator: Pietro Panizza, M.D Ospedale San Raffaele

Layout table for additonal information
Responsible Party: Philips Digital Mammography Sweden AB Identifier: NCT02771444     History of Changes
Other Study ID Numbers: DOC-EMOA-A7UDZ2
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases