Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
Study on Breast Cancer Screening Methods
Brief description of study.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: breast cancer,mammogram,cancer,oncology
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Age: 45 years - 74 years
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Gender: Female
Women of childbearing potential must not be known to be pregnant or lactating
Patients must be scheduled for, or have intent to schedule, a screening mammogram
Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol, to be performed at an American College of Radiology Imaging Network (ACRIN)-qualified facility
Patients must be willing and able to provide a written informed consent
Patients must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) warranting a diagnostic rather than a screening mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are eligible as long as other criteria are met
Patients must not have had a screening mammogram within the last 11 months prior to date of randomization
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
Patients must not have breast enhancements (e.g., implants or injections)
This study investigates the effectiveness of two methods for breast cancer screening: digital tomosynthesis mammography and digital mammography. The purpose of this study is to compare how often advanced breast cancer occurs in participants who are screened using these two methods over a period of 4.5 years. Digital tomosynthesis mammography is a type of breast imaging that creates a three-dimensional picture of the breast, while digital mammography is a standard two-dimensional imaging technique.
Participants in the study will undergo either digital tomosynthesis mammography or digital mammography as part of the screening process. These imaging techniques are used to look for signs of breast cancer in women who do not have any symptoms. The study will take place at facilities qualified by the American College of Radiology Imaging Network. Participants will not receive any payment for their involvement in the study.
- Who can participate: Women who are not pregnant or breastfeeding and are scheduled for a screening mammogram can participate. Participants must not have any symptoms of breast disease and should not have had a mammogram in the last 11 months. Women with a previous history of breast cancer or breast enhancements are not eligible.
- Study details: Participants will undergo either digital tomosynthesis mammography or digital mammography. These procedures involve imaging the breast to detect any signs of cancer. The study will be conducted at facilities qualified by the American College of Radiology Imaging Network.
- Study Timelines: The study will last 4.5 years.
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