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Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

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ClinicalTrials.gov Identifier: NCT03233191
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : December 14, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Canadian Cancer Trials Group (CCTG)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

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.

Condition or disease Intervention/treatment Phase
Breast Screening Procedure: Digital Mammography Procedure: Digital Tomosynthesis Mammography Other: Laboratory Biomarker Analysis Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164946 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to either Digital Breast Tomography (TM) or Full Field Digital Mammography (DM)
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
Actual Study Start Date : July 6, 2017
Estimated Primary Completion Date : August 1, 2025
Estimated Study Completion Date : August 1, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
Experimental: Arm A (digital mammography)
Patients 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.
Procedure: Digital Mammography
Undergo DM
Other Names:
  • Full Field Digital Mammography
  • FFDM

Other: Laboratory Biomarker Analysis
Correlative studies
Other Names:
  • Biomarker analysis
  • genetic analysis
  • PAM50

Experimental: Arm B (digital tomosynthesis mammography)
Patients 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.
Procedure: Digital Tomosynthesis Mammography
Undergo TM
Other Names:
  • DBT
  • Digital Breast Tomosynthesis
  • Digital Tomosynthesis of the Breast

Other: Laboratory Biomarker Analysis
Correlative studies
Other Names:
  • Biomarker analysis
  • genetic analysis
  • PAM50




Primary Outcome Measures :
  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 [ Time Frame: 4.5 years after registration ]
    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.


Secondary Outcome Measures :
  1. Agreement between local and expert study pathologists for all breast lesions (benign and malignant) biopsied during the five years of screening [ Time Frame: Up to 8 years ]
    Measures of agreement such as kappa statistics and concordance coefficients to assess the agreement of local and central pathology readings. In addition, the variability among local pathologists will be examined with respect to the degree of agreement with the central study interpretation. This analysis will utilize mixed models with random effects for local pathologists. There will be up to two central study independent pathologist interpretations for each representative diagnostic slide set.

  2. Breast Imaging-Reporting and Data System (BIRADS) imaging features [ Time Frame: Up to 8 years ]
    The correlation between BIRADS imaging features and histologic and genetic features, such as invasive ductal and invasive lobular histology, high grade, high stage at diagnosis, and aggressive genetic subtypes will be examined. Using data on patients with cancer, estimates of the correlation between the two sets of features (BIRADS imaging features and histologic/genetic features) will be derived. Cluster analysis will be used to identify clusters of patients based on imaging features and will examine the association of these clusters with histology and genetic features. Using data from the fu

  3. Breast-cancer-specific mortality [ Time Frame: Up to 8 years ]
    Breast-cancer-specific mortality between the two study arms will be estimated and compared. Information on cancer recurrence and mortality will be obtained for a period of at least 4.5-8 years on all study participants. Mortality rates will be estimated as the ratio of the number of breast cancer deaths during a time period to the number of person-years at risk. Person-years will be measured as time from randomization to breast cancer death or censoring. Cumulative mortality rates from breast cancer at the end of the study period in each arm will be compared via the relative risk (rate ratio).

  4. Centralized quality control (QC) monitoring program implementation [ Time Frame: Up to 8 years ]

    Centralized QC monitoring program for both DM and TM, which provides rapid feedback on image quality, using quantitative tools, taking advantage of the automated analysis of digital images. The QC program will provide an auditable trail of QC activities and image quality parameters, while at the same time reducing QC effort required by the technologist at the site.

    Constant monitoring of data from all sites will occur, and Root Cause Analysis will be performed for non-compliant items. The remote monitoring system will be evaluated in terms of its percent ?up-time?, technologist compliance (vi


  5. Diagnostic and predictive performance of tomosynthesis mammography (TM) and digital mammography (DM) [AUC] [ Time Frame: Up to 8 years ]
    ROC analysis will be performed to compare the performance characteristics of DM vs TM at each screening visit

  6. Assess the predictive performance of tomosynthesis mammography (TM) and digital mammography (DM) [ Time Frame: Up to 8 years ]
    Compare the predictive characteristics (PPV,NPV,Sens, and Spec) of DM vs TM at each screening visit

  7. Health care costs (including diagnostic procedures and cancer care received) as the result of an episode of breast cancer screening by tomosynthesis mammography (TM) versus digital mammography (DM) [ Time Frame: Up to 8 years ]
    Rates of utilization of key diagnostic procedures (e.g. extra TM or DM views, Ultrasound, Short-term interval follow-up, surgical consultation, percutaneous biopsy with, needle-localized open surgical biopsy, breast MRI) will be estimated; Medicare reimbursement costs will be used to derive a standardized measure of cost per participant; and these costs will be compared across the two study arms. These measures of cost will be compared across study arms using non-parametric methods.

  8. Health care utilization (including cancer care received) of an episode of breast cancer screening by tomosynthesis mammography (TM) versus digital mammography (DM) [ Time Frame: Up to 8 years ]
    Rates of utilization of key diagnostic procedures (e.g. extra TM or DM views, Ultrasound, Short-term interval follow-up, surgical consultation, percutaneous biopsy with, needle-localized open surgical biopsy, breast MRI) will be estimated and compared across the two study arms. The comparisons will be made using regression modeling

  9. Histologically malignant (true positive cases) and benign lesions (false positive cases) [ Time Frame: Up to 8 years ]
    Classification of histologically benign-appearing lesions (false positive cases) will be explored as normal-like or tumor-like using the PAM50 gene expression assay subtype and low, medium, or high proliferation according to a PAM50 proliferation signature, and p53 mutant-like or wild-type-like according to a validated p53-dependent signature, and according to histological features. The benign-appearing (false positive) biopsies will be characterized using digital histologic analysis tools that capture percent of area represented by stroma, epithelium, and fat as well as the density of nuclei

  10. Prevalence of breast cancer subtypes (luminal A, luminal B, HER2+, basal-like) and p53 signature in the two arms [ Time Frame: Up to 8 years ]
    Prevalence of breast cancer subtypes (luminal A, luminal B, HER2+, basal-like) and p53 signature in the two arms will be estimated and compared, overall and stratified on whether cancers were detected through screening or as interval cancers. subtypes in each arm and to compare them across arms. The analysis will be performed overall, and stratified by screen detected or interval detected. Estimates of the prevalence of subtypes and confidence intervals will be developed for each screening round and for the full period of screening. The comparison of rates across arms will be based on multinom

  11. Proportion of women diagnosed with an ?advanced? breast cancer in the two arms [ Time Frame: Up to 8 years ]
    The potential effect of age, menopausal and hormonal status, breast density, and family cancer history will be assessed on the primary endpoint difference between the two arms. Regression modeling will be used to assess the effect of age, menopausal and hormonal status, breast density, and family cancer history. Multiple imputation will be used to handle missing data in the response and the covariates, and a sensitivity analysis to assumptions about the missing data will be performed. An exploratory analysis using alternative definitions of the primary endpoint will also be conducted in order

  12. Quality control (QC) tests useful for determination of image quality and those that are predictive of device failure [ Time Frame: Up to 8 years ]
    QC tests that are useful for determination of image quality and those that are predictive of device failure will be evaluated, in order to recommend an optimal QC program for TM. Tests that are most sensitive to changes in system performance will be established and tests that are inferior and/or redundant and can be eliminated. Changes will be tracked against site records of alterations or repairs to the system, recalibration and changes in imaging parameters. Changes in test results will be observed and if they are suggestive that remedial action is required, we will determine after such acti

  13. Rate of interval cancers [ Time Frame: Up to 8 years ]
    The rate of interval cancers for TM and DM will be compared and the mechanism of diagnosis for these interval cancers will be assessed with categorization by symptomatic vs asymptomatic, and how detected: diagnosed via physical examination, mammography, ultrasound (US), magnetic resonance imaging (MRI) or other technologies. Interval cancers are those that occur between screening examinations. Interval cancer rates for each screening occasion and over the full set of screens will be estimated using Wilson intervals and compared across arms using two-sided tests for binomial proportions. The di

  14. Recall rates [ Time Frame: Up to 8 years ]
    The recall rates for TM versus (vs) DM will be compared. Recall rates are defined as the number of screening examinations that are interpreted as BIRADS 0, 3, 4 and 5 divided by the total number of screening examinations. Recall rates for each screening occasion and over the full set of screens will be estimated using Wilson intervals and compared across arms using two-sided tests for binomial proportions. Logistic regression will be used to analyze potential differences across patient subsets.

  15. Biopsy rates [ Time Frame: Up to 8 years ]
    The biopsy rates for TM versus (vs) DM will be compared. biopsy rates are defined as the number of biopsies divided by the total number of screening examinations. rates for each screening occasion and over the full set of screens will be estimated using Wilson intervals and compared across arms using two-sided tests for binomial proportions. Logistic regression will be used to analyze potential differences across patient subsets

  16. Task-based measure of image quality [ Time Frame: Up to 8 years ]
    Task-based measures of image quality will be refined and implemented to assess the effects of technical parameters, including machine type, and detector spatial and contrast resolution on diagnostic accuracy for TM. the diagnostic accuracy of the resulting Task-based analysis, using mathematical observers, will be assessed from image information using techniques based on signal and noise transfer.

  17. Variability of quality control parameters [ Time Frame: Up to 8 years ]
    The variability of standard quality control parameters will be assessed and compared temporally, within, and across sites for both DM and TM.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  • ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK
  • To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above:

    • 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:

      • Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
      • Currently on hormone therapy
  • Postmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry; for the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to hysterectomy and oophorectomy will be considered postmenopausal; women who no longer have menses due to hysterectomy without oophorectomy will be considered premenopausal until age 52 and postmenopausal thereafter
  • All other postmenopausal women are eligible for inclusion in the biennial screening regimen
  • For those women who cannot be assigned to annual or biennial screening at the time of study entry and randomization because they are postmenopausal, have no family history or known deleterious breast cancer mutation, are not on hormone therapy AND have not had a prior mammogram, breast density will be determined by the radiologist?s recording of it at the time of interpretation of the first study screening examination, either DM or TM; for those who are randomized to TM, radiologists will assign BI-RADS density through review of the DM or synthetic DM portion of the TM examination; such women cannot be part of the planned stratification by screening frequency and are expected to represent far less than 1% of the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) population
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233191


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Locations
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United States, Arizona
Scottsdale Medical Imaging Limited Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Site Public Contact    480-425-4170    investigator@esmil.com   
Principal Investigator: Denise H. Reddy         
United States, California
Kern Radiology Medical Group Inc Recruiting
Bakersfield, California, United States, 93306
Contact: Site Public Contact    661-326-9600      
Principal Investigator: David P. Schale         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Site Public Contact    720-848-0650      
Principal Investigator: Dulcy E. Wolverton         
Penrose-Saint Francis Healthcare Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
The Women's Imaging Center Recruiting
Denver, Colorado, United States, 80209
Contact: Site Public Contact       ecog.rss@jimmy.harvard.edu   
Principal Investigator: Keren Sturtz         
Radiology Imaging Associates Recruiting
Englewood, Colorado, United States, 80112
Contact: Site Public Contact    303-761-9190    research@riaco.com   
Principal Investigator: Lora D. Barke         
UCHealth Lone Tree Health Center Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Site Public Contact       ecog.rss@jimmy.harvard.edu   
Principal Investigator: Dulcy E. Wolverton         
United States, Delaware
Helen F Graham Cancer Center Recruiting
Newark, Delaware, United States, 19713
Contact: Site Public Contact    302-623-4450    KDempsey@christianacare.org   
Principal Investigator: Gregory A. Masters         
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Site Public Contact    404-303-3355    ClinicalTrials@northside.com   
Principal Investigator: Lynn D. Baxter         
Northeast Georgia Medical Center Braselton Recruiting
Braselton, Georgia, United States, 30517
Contact: Site Public Contact    770-219-8800    cancerpatient.navigator@nghs.com   
Principal Investigator: Charles H. Nash         
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Recruiting
Savannah, Georgia, United States, 31405
Contact: Site Public Contact       ecog.rss@jimmy.harvard.edu   
Principal Investigator: Howard A. Zaren         
United States, Hawaii
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Erin Capps         
United States, Idaho
Saint Luke's Mountain States Tumor Institute Recruiting
Boise, Idaho, United States, 83712
Contact: Site Public Contact       ecog.rss@jimmy.harvard.edu   
Principal Investigator: Alison K. Conlin         
United States, Illinois
John H Stroger Jr Hospital of Cook County Recruiting
Chicago, Illinois, United States, 60612
Contact: Site Public Contact    312-864-5204      
Principal Investigator: Thomas E. Lad         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Site Public Contact    217-876-4740    rhamrick@dmhhs.org   
Principal Investigator: Bryan A. Faller         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Site Public Contact    800-446-5532    Research@carle.com   
Principal Investigator: Kendrith M. Rowland         
United States, Indiana
Indiana University/Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Site Public Contact    317-278-5632    iutrials@iu.edu   
Principal Investigator: Steven M. Westphal         
United States, Iowa
Mercy Medical Center - Des Moines Recruiting
Des Moines, Iowa, United States, 50314
Contact: Site Public Contact    308-398-6518    clinicaltrials@sfmc-gi.org   
Principal Investigator: Mehmet S. Copur         
United States, Louisiana
Mary Bird Perkins Cancer Center Suspended
Baton Rouge, Louisiana, United States, 70809
Woman's Hospital Recruiting
Baton Rouge, Louisiana, United States, 70817
Contact: Site Public Contact       ecog.rss@jimmy.harvard.edu   
Principal Investigator: James F. Ruiz         
University Medical Center New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Site Public Contact    504-903-3000    emede1@lsuhsc.edu   
Principal Investigator: Mignonne Morrell         
Louisiana State University Health Sciences Center Shreveport Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Site Public Contact    318-813-1412    JRowel@lsuhsc.edu   
Principal Investigator: Jerry McLarty         
United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Site Public Contact    508-856-3216    cancer.research@umassmed.edu   
Principal Investigator: Gopal Vijayaraghavan         
United States, Michigan
Saint Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Site Public Contact    734-712-3671    stephanie.couch@stjoeshealth.org   
Principal Investigator: Philip J. Stella         
University of Michigan Comprehensive Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site Public Contact    800-865-1125      
Principal Investigator: Stephanie Patterson         
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Site Public Contact    616-391-1230    crcwm-regulatory@crcwm.org   
Principal Investigator: Kathleen J. Yost         
United States, Minnesota
Essentia Health Cancer Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Site Public Contact    218-786-3308    CancerTrials@EssentiaHealth.org   
Principal Investigator: Bret E. Friday         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Site Public Contact    952-993-1517    mmcorc@healthpartners.com   
Principal Investigator: David M. King         
United States, Nevada
Carson Tahoe Regional Medical Center Recruiting
Carson City, Nevada, United States, 89703
Contact: Site Public Contact    702-384-0013    research@sncrf.org   
Principal Investigator: John A. Ellerton         
United States, New Jersey
Saint Peter's University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Susan A. McManus         
Riverview Medical Center/Booker Cancer Center Recruiting
Red Bank, New Jersey, United States, 07701
Contact: Site Public Contact    732-530-2382      
Principal Investigator: Bokran Won         
United States, New Mexico
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Site Public Contact    505-925-0366    LByatt@nmcca.org   
Principal Investigator: Ursa A. Brown-Glaberman         
United States, New York
Montefiore Medical Center-Einstein Campus Recruiting
Bronx, New York, United States, 10461
Contact: Site Public Contact    718-379-6866    aaraiza@montefiore.org   
Principal Investigator: Joseph A. Sparano         
Montefiore Medical Center-Weiler Hospital Suspended
Bronx, New York, United States, 10461
Arnot Ogden Medical Center/Falck Cancer Center Recruiting
Elmira, New York, United States, 14905
Contact: Site Public Contact    607-271-7000      
Principal Investigator: Chi K. Tsang         
Columbia University/Herbert Irving Cancer Center Recruiting
New York, New York, United States, 10032
Contact: Site Public Contact    212-305-6361    nr2616@cumc.columbia.edu   
Principal Investigator: Ralph T. Wynn         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact    212-639-7592      
Principal Investigator: Victoria L. Mango         
Weill Medical College of Cornell University Recruiting
New York, New York, United States, 10065
Contact: Site Public Contact    212-746-1848      
Principal Investigator: Michele B. Drotman         
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Site Public Contact    877-668-0683    cancerclinicaltrials@med.unc.edu   
Principal Investigator: Cherie Kuzmiak         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Site Public Contact    888-275-3853      
Principal Investigator: Lars J. Grimm         
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Site Public Contact    336-713-6771      
Principal Investigator: Kelly Brozzetti Cronin         
United States, Ohio
Aultman Health Foundation Recruiting
Canton, Ohio, United States, 44710
Contact: Site Public Contact    330-363-6891      
Principal Investigator: Shruti Trehan         
University of Cincinnati/Barrett Cancer Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Site Public Contact    513-558-4553    uchealthnews@uc.edu   
Principal Investigator: Lawrence D. Sobel         
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Site Public Contact    800-293-5066    Jamesline@osumc.edu   
Principal Investigator: Jeffrey R. Hawley         
United States, Pennsylvania
Easton Hospital Suspended
Easton, Pennsylvania, United States, 18042
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Site Public Contact    877-284-2000      
Principal Investigator: Betty Shindel         
Wexford Health and Wellness Pavilion Recruiting
Wexford, Pennsylvania, United States, 15090
Contact: Site Public Contact    412-359-3043    ddefazio@wpahs.org   
Principal Investigator: Betty Shindel         
United States, South Carolina
MUSC Health East Cooper Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Site Public Contact    843-792-9321    hcc-clinical-trials@musc.edu   
Principal Investigator: Dag Pavic         
Spartanburg Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Site Public Contact    864-560-6104    kmertz-rivera@gibbscc.org   
Principal Investigator: Amarinthia (Amy) Curtis         
United States, Tennessee
Baptist Memorial Hospital and Cancer Center-Memphis Suspended
Memphis, Tennessee, United States, 38120
Baptist Memorial Hospital for Women Recruiting
Memphis, Tennessee, United States, 38120
Contact: Site Public Contact    901-226-1366    BCCclintrials@bmhcc.org   
Principal Investigator: Evelyn W. Gayden         
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Site Public Contact    800-811-8480      
Principal Investigator: Reagan Leverett         
United States, Texas
UT Southwestern/Simmons Cancer Center-Dallas Recruiting
Dallas, Texas, United States, 75390
Contact: Site Public Contact    214-648-7097    canceranswerline@UTSouthwestern.edu   
Principal Investigator: W. P. Evans         
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Site Public Contact    434-243-6303    PAS9E@virginia.edu   
Principal Investigator: Jennifer A. Harvey         
Sentara Leigh Hospital Recruiting
Norfolk, Virginia, United States, 23502
Contact: Site Public Contact    757-388-5109    djoverto@sentara.com   
Principal Investigator: John K. Plemmons         
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Contact: Site Public Contact    757-388-2406      
Principal Investigator: John K. Plemmons         
United States, Wisconsin
ThedaCare Regional Cancer Center Recruiting
Appleton, Wisconsin, United States, 54911
Contact: Site Public Contact    844-510-3600      
Principal Investigator: Susan Sung         
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Site Public Contact    800-622-8922      
Principal Investigator: Mai A. Elezaby         
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Site Public Contact    800-782-8581    oncology.clinical.trials@marshfieldresearch.org   
Principal Investigator: Adedayo A. Onitilo         
ProHealth D N Greenwald Center Recruiting
Mukwonago, Wisconsin, United States, 53149
Contact: Site Public Contact    888-823-5923    ctsucontact@westat.com   
Principal Investigator: Timothy R. Wassenaar         
ProHealth Oconomowoc Memorial Hospital Recruiting
Oconomowoc, Wisconsin, United States, 53066
Contact: Site Public Contact    262-928-7878      
Principal Investigator: Timothy R. Wassenaar         
UW Cancer Center at ProHealth Care Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Site Public Contact    262-928-5539    Chanda.miller@phci.org   
Principal Investigator: Timothy R. Wassenaar         
Canada, British Columbia
BCCA-Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Site Public Contact    888-939-3333      
Principal Investigator: Paula B. Gordon         
Canada, Ontario
Ottawa Hospital and Cancer Center-General Campus Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Site Public Contact    613-761-4395      
Principal Investigator: Jean M. Seely         
Odette Cancer Centre- Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Site Public Contact    416-480-5000      
Principal Investigator: Roberta A. Jong         
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Canadian Cancer Trials Group (CCTG)
Investigators
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Principal Investigator: Etta Pisano ECOG-ACRIN Cancer Research Group

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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT03233191     History of Changes
Other Study ID Numbers: EA1151
NCI-2017-01111 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EA1151 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
EA1151 ( Other Identifier: DCP )
EA1151 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
U10CA180794 ( U.S. NIH Grant/Contract )
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
Digital Mammography
Breast Tomography
Screening Mammography
TMIST