Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

Recruiting
45 years - 74 years
Female
Phase N/A
1 Location

Brief description of study

This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer.

Detailed description of study

The purpose of this study is to compare the proportions of participants in the tomosynthesis mammography (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).
Participants will not be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: breast cancer,mammogram,cancer,oncology
  • Age: 45 years - 74 years
  • Gender: Female

Inclusion Criteria
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)

Updated on 04 Aug 2024. Study ID: 1708650574 (RADY-ECOG-WESTPHAL-EA1151)

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