Purpose of this Study
If you choose to join this study, you will:
- Be randomized (like the flip of a coin) to screening with Tomosynthesis Mammography (TM) or Digital Mammography (DM)
The frequency and number of screening mammograms will vary with your menopausal status and whether you have breast cancer risk factors.
-- All premenopausal women will have annual screening
-- Postmenopausal women will have screening every 2 years unless they have any specific risk factors
- Have either three-dimensional (3D) Tomosynthesis Mammography or two-dimensional (2D) Digital Mammography
-- Get screened every year for four more years - for a total of five mammograms, or
-- Every other year - for a total of three mammograms
- Be followed for 4.5 to 8 years
- Be randomized (like the flip of a coin) to screening with Tomosynthesis Mammography (TM) or Digital Mammography (DM)
The frequency and number of screening mammograms will vary with your menopausal status and whether you have breast cancer risk factors.
-- All premenopausal women will have annual screening
-- Postmenopausal women will have screening every 2 years unless they have any specific risk factors
- Have either three-dimensional (3D) Tomosynthesis Mammography or two-dimensional (2D) Digital Mammography
-- Get screened every year for four more years - for a total of five mammograms, or
-- Every other year - for a total of three mammograms
- Be followed for 4.5 to 8 years
Who Can Participate?
Eligibility
Women aged 45 to 74
Age Range
40-110
Sex/Genders
Female (cisgender)
Looking for Healthy Participants
Yes
What is Involved?
We are doing this study to compare two different screening mammography methods in pre- and post-menopausal women to understand whether one method is better than the other at finding life-threatening breast cancers.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
Principal Investigator
Lars
Grimm
Protocol Number
PRO00086885
NCT ID
NCT03233191
Phase
III
Enrollment Status
OPEN TO ACCRUAL