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Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
 
Region Sponsors
Mid-Atlantic
ECOG-ACRIN Cancer Research Group
 
Acronym KP IRB No.
EA1151 MA-18-194
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Pre-menopausal and Post-menopausal aged 45-74 scheduled for, or have intent to schedule, a screening mammogram.
 
Purpose
The purpose of the EA1151 (TMIST) trial is to determine whether screening for breast cancer with a newer technology called tomosynthesis mammography- TM (3-D) is more effective compared to the standard digital mammography- DM (2-D) in detecting early and aggressive breast cancers in women 45 to 74 years old.
 
Detailed Description
 
Gender Age Limit
Female 45 - 74 years
 
Inclusion Criteria
  • 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
  • Breast density will be determined by prior mammography reports, when available. All other risk factors used to determine patient eligibility for annual or biennial screening will be determined by subject self-report
  • Please contact study personnel for more eligibility criteria
 
Exclusion Criteria
  • Women of childbearing potential must not be known to be pregnant or lactating
  • 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)
  • Please contact study personnel for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • EA1151 (TMIST)
  • Preventative Medicine
  • Screening Mammogram
 
KP Clinical Facility
  • Largo Medical Center
 
Clinical Area
  • Preventative Medicine


Principal Investigator:
Ainsley Maclean, MD
Contact Information:
- Leslie Greenberg, RN
-3018166768
-leslie.k.greenberg@kp.org
-Gaithersburg Medical Center


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