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EA1151: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

Primary Objective

To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4). To assess the potential effect of age, menopausal and hormonal status, breast density, and family cancer history on the primary endpoint difference between the two arms.

Study category: Cancer

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Description

Participants in this trial will be randomized to receive either 2D or 3D mammograms for the first 5 years of the research study, either ever year or every other year depending on personal risk factors. Information will be collected on breast cancer status for 8 years in total.

Details
Age

Adult

Eligibility

Women aged 45-74 years who do not have a personal history of breast cancer.

Detailed Eligibility: Patients must also have a screening mammogram scheduled, or intend to schedule, at either the Anschutz Medical Campus or at Lone Tree. Patients must not have had a screening mammogram within the last 11 months.

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Screening

Scope

National

Locations

Highlands Ranch Hospital
University of Colorado Hospital

Principal Investigator
Dulcy Wolverton

Dulcy Wolverton

Study ID

Protocol Number: 18-0392

More information available at ClinicalTrials.gov: NCT03233191

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