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Low Dose Tomosynthesis Compared to Traditional Tomosynthesis

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ClinicalTrials.gov Identifier: NCT02771444
Recruitment Status : Terminated (Decision by sponsor, development stopped.)
First Posted : May 13, 2016
Last Update Posted : March 26, 2018
Sponsor:
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.


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



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

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 ClinicalTrials.gov identifier (NCT number): NCT02771444


Locations
Italy
Ospedale San Rafaele
Milan, Italy
Sponsors and Collaborators
Philips Digital Mammography Sweden AB
Investigators
Principal Investigator: Pietro Panizza, M.D Ospedale San Raffaele

Responsible Party: Philips Digital Mammography Sweden AB
ClinicalTrials.gov 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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases