NCT00008346

Brief Summary

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. It is not yet known which type of mammography is more effective in detecting breast cancer. PURPOSE: Screening and diagnostic trial to compare the effectiveness of two types of mammography in detecting breast cancer in women.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49,528

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Oct 2001

Typical duration for not_applicable breast-cancer

Geographic Reach
2 countries

32 active sites

Status
completed

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

January 6, 2001

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2001

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2005

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

3.3 years

First QC Date

January 6, 2001

Last Update Submit

July 7, 2017

Conditions

Keywords

breast cancer

Study Arms (2)

SFM then FFDM

OTHER

Screen Film Mammography (SFM) followed by Full Field Digital Mammography (FFDM)

Diagnostic Test: Full Field Digital MammographyDiagnostic Test: Screen Film Mammography

FFDM then SFM

OTHER

Full Field Digital Mammography (FFDM) followed by Screen Film Mammography (SFM)

Diagnostic Test: Full Field Digital MammographyDiagnostic Test: Screen Film Mammography

Interventions

Radiologic test to screen women for Breast cancer using digital detectors

Also known as: FFDM, Digital Mammography
FFDM then SFMSFM then FFDM

Radiologic test to screen women for Breast cancer using plain film detectors a resolution screen

Also known as: SFM, Plain Film Mamography
FFDM then SFMSFM then FFDM

Eligibility Criteria

AgeUp to 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • All women who have breast implants. 4.2.3 Any woman who is pregnant or has reason to believe that she might be pregnant.
  • Participants who cannot, for any reason, undergo follow-up screen-film mammography at the participating institution or provide mammograms from another institution for review for one year after study entry.
  • All women with a history of breast cancer treated with lumpectomy. Note: Women with a history of breast cancer treated with mastectomy who have now returned to a screening population will still be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095, United States

Location

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Washington Radiology Associates, P.C.

Washington D.C., District of Columbia, 20037, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Emory Health Care Clinic

Atlanta, Georgia, 30322, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60610, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

La Grange Memorial Hospital

La Grange, Illinois, 60525, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic - Burlington

Burlington, Massachusetts, 01805, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

Shore Memorial Hospital

Somers Point, New Jersey, 08244, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10003, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029-6574, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Elizabeth Wende Breast Clinic

Rochester, New York, 14620, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267-0772, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212-4772, United States

Location

Roger Williams Medical Center/BUSM

Providence, Rhode Island, 02908-4735, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75390-8585, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

University of Washington Medical Center

Seattle, Washington, 98112, United States

Location

Sunnybrook and Women's College Health Sciences Centre

North York, Ontario, M4N 3M5, Canada

Location

Related Publications (9)

  • Hendrick RE, Pisano ED, Averbukh A, Moran C, Berns EA, Yaffe MJ, Herman B, Acharyya S, Gatsonis C. Comparison of acquisition parameters and breast dose in digital mammography and screen-film mammography in the American College of Radiology Imaging Network digital mammographic imaging screening trial. AJR Am J Roentgenol. 2010 Feb;194(2):362-9. doi: 10.2214/AJR.08.2114.

    PMID: 20093597BACKGROUND
  • Tosteson AN, Stout NK, Fryback DG, Acharyya S, Herman BA, Hannah LG, Pisano ED; DMIST Investigators. Cost-effectiveness of digital mammography breast cancer screening. Ann Intern Med. 2008 Jan 1;148(1):1-10. doi: 10.7326/0003-4819-148-1-200801010-00002.

    PMID: 18166758BACKGROUND
  • Baum JK, Hanna LG, Acharyya S, Mahoney MC, Conant EF, Bassett LW, Pisano ED. Use of BI-RADS 3-probably benign category in the American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial. Radiology. 2011 Jul;260(1):61-7. doi: 10.1148/radiol.11101285. Epub 2011 Apr 18.

  • Hendrick RE, Cole EB, Pisano ED, Acharyya S, Marques H, Cohen MA, Jong RA, Mawdsley GE, Kanal KM, D'Orsi CJ, Rebner M, Gatsonis C. Accuracy of soft-copy digital mammography versus that of screen-film mammography according to digital manufacturer: ACRIN DMIST retrospective multireader study. Radiology. 2008 Apr;247(1):38-48. doi: 10.1148/radiol.2471070418.

  • Pisano ED, Hendrick RE, Yaffe MJ, Baum JK, Acharyya S, Cormack JB, Hanna LA, Conant EF, Fajardo LL, Bassett LW, D'Orsi CJ, Jong RA, Rebner M, Tosteson AN, Gatsonis CA; DMIST Investigators Group. Diagnostic accuracy of digital versus film mammography: exploratory analysis of selected population subgroups in DMIST. Radiology. 2008 Feb;246(2):376-83. doi: 10.1148/radiol.2461070200.

  • Bloomquist AK, Yaffe MJ, Pisano ED, Hendrick RE, Mawdsley GE, Bright S, Shen SZ, Mahesh M, Nickoloff EL, Fleischman RC, Williams MB, Maidment AD, Beideck DJ, Och J, Seibert JA. Quality control for digital mammography in the ACRIN DMIST trial: part I. Med Phys. 2006 Mar;33(3):719-36. doi: 10.1118/1.2163407.

  • Yaffe MJ, Bloomquist AK, Mawdsley GE, Pisano ED, Hendrick RE, Fajardo LL, Boone JM, Kanal K, Mahesh M, Fleischman RC, Och J, Williams MB, Beideck DJ, Maidment AD. Quality control for digital mammography: part II. Recommendations from the ACRIN DMIST trial. Med Phys. 2006 Mar;33(3):737-52. doi: 10.1118/1.2164067.

  • Pisano ED, Gatsonis CA, Yaffe MJ, Hendrick RE, Tosteson AN, Fryback DG, Bassett LW, Baum JK, Conant EF, Jong RA, Rebner M, D'Orsi CJ. American College of Radiology Imaging Network digital mammographic imaging screening trial: objectives and methodology. Radiology. 2005 Aug;236(2):404-12. doi: 10.1148/radiol.2362050440. Epub 2005 Jun 16.

  • Pisano ED, Gatsonis C, Hendrick E, Yaffe M, Baum JK, Acharyya S, Conant EF, Fajardo LL, Bassett L, D'Orsi C, Jong R, Rebner M; Digital Mammographic Imaging Screening Trial (DMIST) Investigators Group. Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med. 2005 Oct 27;353(17):1773-83. doi: 10.1056/NEJMoa052911. Epub 2005 Sep 16.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Etta Pisano, MD

    UNC Lineberger Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

October 1, 2001

Primary Completion

February 1, 2005

Study Completion

June 30, 2005

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations