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.|
|ClinicalTrials.gov Identifier: NCT02771444|
Recruitment Status : Terminated (Decision by sponsor, development stopped.)
First Posted : May 13, 2016
Last Update Posted : March 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Device: Tomo Assessment||Not Applicable|
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.|
|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|
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
- X-ray dose [ Time Frame: 4 months ]X-ray dose will be measured per projection.
- 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
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
|Ospedale San Rafaele|
|Principal Investigator:||Pietro Panizza, M.D||Ospedale San Raffaele|