Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
4 other identifiers
interventional
108,508
11 countries
149
Brief Summary
This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2017
Longer than P75 for phase_3
149 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 5, 2017
CompletedFirst Posted
Study publicly available on registry
July 28, 2017
CompletedStudy Start
First participant enrolled
September 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
March 23, 2026
March 1, 2026
11.3 years
July 5, 2017
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of women diagnosed with 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 follow up after the last screen
The cumulative proportions of participants experiencing the primary endpoint in the two study arms will be compared. The primary comparison of the two study arms will be approached from an Intent-to-Treat perspective and will be based on a two-sided test for comparing binomial proportions.
4.5 years after last registration
Secondary Outcomes (17)
Agreement between local and expert study pathologists for all breast lesions (benign and malignant) biopsied during the five years of screening
Up to 8 years
Breast Imaging-Reporting and Data System (BIRADS) imaging features
Up to 8 years
Breast-cancer-specific mortality
Up to 8 years
Centralized quality control (QC) monitoring program implementation
Up to 8 years
Diagnostic and predictive performance of tomosynthesis mammography (TM) and digital mammography (DM) [AUC]
Up to 8 years
- +12 more secondary outcomes
Study Arms (2)
Arm A (digital mammography)
EXPERIMENTALPatients undergo bilateral screening DM with standard CC and MLO views at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
Arm B (digital tomosynthesis mammography)
EXPERIMENTALPatients undergo manufacturer-defined screening TM at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
Interventions
Undergo TM
Correlative studies
Undergo DM
Eligibility Criteria
You may qualify if:
- 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.
- 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)
- ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK
- Patients are pre-menopausal; OR
- Post-menopausal aged 45-69 with any of the following three risks factors:
- Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
- Family history of breast cancer (first degree relative with breast cancer), or, positive genetic testing for any deleterious genes that indicate an increased risk for breast cancer, or
- Currently on hormone therapy; OR
- Post-menopausal ages 70-74 with either of the following two risk factors:
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ECOG-ACRIN Cancer Research Grouplead
- National Cancer Institute (NCI)collaborator
- Canadian Cancer Trials Group (CCTG)collaborator
Study Sites (149)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Mobile Infirmary Medical Center
Mobile, Alabama, 36607, United States
Banner-University Medical Center Phoenix
Phoenix, Arizona, 85006, United States
University of Arizona College of Medicine Phoenix
Phoenix, Arizona, 85006, United States
Valleywise Comprehensive Health Center - Phoenix
Phoenix, Arizona, 85008, United States
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054, United States
Scottsdale Medical Imaging Limited
Scottsdale, Arizona, 85258, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Kern Radiology Medical Group Inc
Bakersfield, California, 93306, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Kaiser Permanente-Modesto
Modesto, California, 95356, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
The Women's Imaging Center
Denver, Colorado, 80209, United States
Radiology Imaging Associates
Englewood, Colorado, 80112, United States
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, 80129, United States
UCHealth Lone Tree Health Center
Lone Tree, Colorado, 80124, United States
Helen F Graham Cancer Center
Newark, Delaware, 19713, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northeast Georgia Medical Center Braselton
Braselton, Georgia, 30517, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Bromenn Lifecare Center
Bloomington, Illinois, 61701, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
Carle at The Riverfront
Danville, Illinois, 61832, United States
Carle on Fairchild
Danville, Illinois, 61832, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Carle Hoopeston Regional Health Center
Hoopeston, Illinois, 60942, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Saint Mary Medical Center
Hobart, Indiana, 46342, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
The Community Hospital
Munster, Indiana, 46321, United States
Women's Diagnostic Center - Munster
Munster, Indiana, 46321, United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, 46383, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Woman's Hospital
Baton Rouge, Louisiana, 70817, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Ochsner LSU Health Saint Mary's Medical Center
Shreveport, Louisiana, 71101, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
Kaiser Permanente - Kensington Medical Center
Kensington, Maryland, 20895, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Sanford Thief River Falls Medical Center
Thief River Falls, Minnesota, 56701, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, 55792, United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi, 38671, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703, United States
Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901, United States
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, 07701, United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
Arnot Ogden Medical Center/Falck Cancer Center
Elmira, New York, 14905, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
NYP/Weill Cornell Medical Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of North Carolina-Hillsborough Campus
Hillsborough, North Carolina, 27278, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Southpointe-Sanford Medical Center Fargo
Fargo, North Dakota, 58103, United States
Cleveland Clinic Cancer Center Beachwood
Beachwood, Ohio, 44122, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Easton Hospital
Easton, Pennsylvania, 18042, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania, 15090, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Richland Hospital
Columbia, South Carolina, 29203, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
MUSC Health East Cooper
Mt. Pleasant, South Carolina, 29464, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Spartanburg Medical Center - Mary Black Campus
Spartanburg, South Carolina, 29307, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920, United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee, 38120, United States
Baptist Memorial Hospital for Women
Memphis, Tennessee, 38120, United States
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Memorial Hermann Texas Medical Center
Houston, Texas, 77030, United States
Memorial Hermann Imaging Center - Upper Kirby
Houston, Texas, 77098, United States
University Hospital
San Antonio, Texas, 78229, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Bon Secours Westchester Emergency Center
Midlothian, Virginia, 23113, United States
Sentara Leigh Hospital
Norfolk, Virginia, 23502, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Sentara Princess Anne Hospital
Virginia Beach, Virginia, 23456, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin, 54880, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
CERIM
Buenos Aires, 1425, Argentina
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Saint Joseph's Health Care London
London, Ontario, N6A 4V2, Canada
Ottawa Hospital and Cancer Center-General Campus
Ottawa, Ontario, K1H 8L6, Canada
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Hopital Du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
CHU de Quebec-Hopital du Saint-Sacrement (HSS)
Québec, Quebec, G1S 4L8, Canada
Hospital Sotero Del Rio
Puente Alto, Santiago Metropolitan, 8207257, Chile
Ospedale Ca Foncello di Treviso - ULSS 2 Marca Trevigiana
Treviso, 31100, Italy
Oncosalud S.A.C.
Lima, Lima 41, Peru
San Juan City Hospital
San Juan, 00936, Puerto Rico
National Cancer Center-Korea
Goyang-si, Gyeonggi-do, 410-769, South Korea
Parc Tauli Sabadell Hospital Universitari
Sabadell, Barcelona, 08208, Spain
Taipei Veterans General Hospital
Taipai, 112, Taiwan
Chiang Mai University
Chiang Mai, Muang, 50200, Thailand
Related Publications (1)
Maki AK, Mawdsley GE, Mainprize JG, Pisano ED, Shen SZ, Alonzo-Proulx O, Yaffe MJ. Quality control for digital tomosynthesis in the ECOG-ACRIN EA1151 TMIST trial. Med Phys. 2023 Dec;50(12):7441-7461. doi: 10.1002/mp.16786. Epub 2023 Oct 13.
PMID: 37830895DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Etta Pisano
ECOG-ACRIN Cancer Research Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2017
First Posted
July 28, 2017
Study Start
September 28, 2017
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2030
Last Updated
March 23, 2026
Record last verified: 2026-03