An interventional study of 3D mammograpgy system in Breast Cancer, sponsored by Hologic, Inc.. Completed at 1 site in United States. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Hologic, Inc. · Not applicable, Interventional, and Diagnostic
The purpose of this study is to conduct an initial investigation into whether an alternative method of using 3D imaging might offer accurate diagnostic performance at a reduced patient radiation exposure in comparison to conventional 2D screening and diagnostic mammography and conventional 2D + 3D imaging methods.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 110 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hologic, Inc. is the lead sponsor of 28 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients returning with an area of interest will undergo investigational 3D imaging in 2 modes of imaging to the breast of interest and compare to the subjects standard of care imaging
Device: 3D mammograpgy system
In addition to the standard care diagnostic imaging, all participants underwent two experimental acquisitions, in two projections (Cranio-Caudal and Mediolateral Oblique) on the breast of concern: one acquisition in Mode A (narrow angle acquisition) and one acquisition in Mode B (wide angle acquisition). The experimental imaging is compared to the standard of care imaging
Also known as: Selenia Dimensions, Tomosynthesis
If the new imaging modes are successful, they will represent a method of reducing patient exposure for future imaging because they are designed to be used in 3D imaging only.
Time frame: Fall 2010
The record gives a start of Oct 2009, a primary completion of Sep 2010 and a completion of Oct 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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