Breast CancerDMISTNCT00008346
Digital Mammography Screening Trial (ACRIN6652)
A study testing Full Field Digital Mammography and Screen Film Mammography in people with Breast Cancer, run by American College of Radiology Imaging Network at 32 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Full Field Digital Mammography and Screen Film Mammography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49,528 participants
- Where
- 32 sitesin 2 countries
- Study dates
- Oct 2001to 30 Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
4.1 Inclusion Criteria 4.1.1 All consecutive women presenting for screening mammography at the participating institutions will be eligible.
4.1.2 Signed study-specific informed consent. See Appendix I. 4.2 Exclusion Criteria 4.2.1 All women who have presented with a complaint of a focal dominant lump or a bloody or clear nipple discharge.
4.2.2 All women who have breast implants. 4.2.3 Any woman who is pregnant or has reason to believe that she might be pregnant.
4.2.4 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.
4.2.5 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.
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States31 sites
Emory Health Care Clinic
Atlanta, Georgia, 30322
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Clinic - Burlington
Burlington, Massachusetts, 01805
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60610
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267-0772
Simmons Cancer Center - Dallas
Dallas, Texas, 75390-8585
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242-1002
La Grange Memorial Hospital
La Grange, Illinois, 60525
Monmouth Medical Center
Long Branch, New Jersey, 07740-6395
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095
Memorial Sloan-Kettering Cancer Center
New York, New York, 10003
Mount Sinai School of Medicine
New York, New York, 10029-6574
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
Roger Williams Medical Center/BUSM
Providence, Rhode Island, 02908-4735
Elizabeth Wende Breast Clinic
Rochester, New York, 14620
William Beaumont Hospital
Royal Oak, Michigan, 48073
University of California Davis Cancer Center
Sacramento, California, 95817
University of Washington Medical Center
Seattle, Washington, 98112
Shore Memorial Hospital
Somers Point, New Jersey, 08244
Siteman Cancer Center
St Louis, Missouri, 63110
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Washington Radiology Associates, P.C.
Washington D.C., District of Columbia, 20037
Canada1 site
Sunnybrook and Women's College Health Sciences Centre
North York, Ontario, M4N 3M5
About this study
Official title: Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women
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.
Read the detailed description
OBJECTIVES:
- Compare the diagnostic performance of digital mammography vs screen-film mammography, as measured by the area under the Receiver Operating Characteristic (ROC) curve, sensitivity, specificity, and positive and negative predictive values, in the detection of breast cancer in women.
- Compare the diagnostic accuracy of the digital mammogram obtained using each of the individual manufacturer's digital units vs screen-film mammography through retrospective reader studies.
- Determine the effects of patient characteristics, including age, lesion type, pathologic diagnosis, menopausal and hormonal status, breast density, and family history, on diagnostic accuracy of digital mammography.
- Determine the effects of technical parameters, including display type, machine type, and detector spatial and contrast resolution, on diagnostic accuracy of digital mammography.
- Determine the effect of reduced false-positive mammograms that are expected with digital mammography on the health-related quality of life and personal anxiety of women undergoing this screening experience.
- Compare the diagnostic performance of digital mammography with the rate of cancer in a set of cases through a retrospective reader study.
- Compare the effect of softcopy vs printed film display on the diagnostic performance of digital mammography through a retrospective reader study.
- Compare the effect of breast density on the diagnostic accuracy of digital mammography vs screen-film mammography through a retrospective reader study.
- Compare the image quality and breast radiation dose in digital vs screen-film mammography in these participants.
- Determine the temporal variations in image quality, breast radiation dose, and other quality control parameters in the participating study centers.
OUTLINE: This is a randomized, multicenter study. Participants with postitive screening results are stratified according to age (under 50 vs 50-59 vs 60-70 vs over 70). Participants are randomized to one of two treatment arms.
- Arm I: Participants undergo a two-view screen-film mammogram followed by a two-view digital mammogram of each breast.
- Arm II: Participants undergo a two-view digital mammogram followed by a two-view screen-film mammogram of each breast.
Quality of life is assessed before the screening mammogram in the first 800 women enrolled. In an additional 1,200 participants (600 with positive screening results and 600 with negative screening results), quality of life is assessed shortly after the screening mammogram and at 1 year.
Participants are followed at 1 year with a repeat screen-film or digital mammogram.
PROJECTED ACCRUAL: A total of 49,500 participants (24,750 per arm) will be accrued for this study within 18 months.
- Conditions
- Breast Cancer
- Being tested
- Full Field Digital Mammography, Screen Film Mammography
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Field Digital MammographyDiagnostic test
Also called FFDM, Digital Mammography
Radiologic test to screen women for Breast cancer using digital detectors
Screen Film MammographyDiagnostic test
Also called SFM, Plain Film Mamography
Radiologic test to screen women for Breast cancer using plain film detectors a resolution screen
| Study group | Role | What they receive |
|---|---|---|
| SFM then FFDM | Other | Screen Film Mammography (SFM) followed by Full Field Digital Mammography (FFDM) Receives: Diagnostic Test: Full Field Digital Mammography; Diagnostic Test: Screen Film Mammography |
| FFDM then SFM | Other | Full Field Digital Mammography (FFDM) followed by Screen Film Mammography (SFM) Receives: Diagnostic Test: Full Field Digital Mammography; Diagnostic Test: Screen Film Mammography |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startOct 2001
- Primary completionFeb 2005
- Study completion30 Jun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49,528 participants (actual)
Sponsor and investigators
- Lead sponsor
- American College of Radiology Imaging Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Etta Pisano, MD, Study chair, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00008346
- Sponsor's protocol ID
- CDR0000068399
- Other IDs
- ACRIN-6652, U01CA080098, U01CA079778
- Acronym
- DMIST
- Status last verified
- Jul 2017
- First submitted
- 6 Jan 2001
- Last updated
- 11 Jul 2017
- Results posted
- No
Publications
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.
PubMed 20093597Tosteson 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.
PubMed 18166758Baum 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.
PubMed 21502382Hendrick 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.
PubMed 18372463Pisano 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.
PubMed 18227537Bloomquist 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.
PubMed 16878575Yaffe 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.
PubMed 16878576Pisano 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.
PubMed 15961755Pisano 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.
PubMed 16169887
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women
- ClinicalTrials.gov ID
- NCT00008346
- Acronym / sponsor ID
- DMIST / CDR0000068399
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49,528 participants (actual)
- Lead sponsor
- American College of Radiology Imaging NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2001 (actual)
- Primary completion
- Feb 2005 (actual)
- Study completion
- 30 Jun 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Compare the diagnostic performance of digital mammography vs screen-film mammography, as measured by the area under the Receiver Operating Characteristic (ROC) curve, sensitivity, specificity, and positive and negative predictive values, in the detection of breast cancer in women.
- Compare the diagnostic accuracy of the digital mammogram obtained using each of the individual manufacturer's digital units vs screen-film mammography through retrospective reader studies.
- Determine the effects of patient characteristics, including age, lesion type, pathologic diagnosis, menopausal and hormonal status, breast density, and family history, on diagnostic accuracy of digital mammography.
- Determine the effects of technical parameters, including display type, machine type, and detector spatial and contrast resolution, on diagnostic accuracy of digital mammography.
- Determine the effect of reduced false-positive mammograms that are expected with digital mammography on the health-related quality of life and personal anxiety of women undergoing this screening experience.
- Compare the diagnostic performance of digital mammography with the rate of cancer in a set of cases through a retrospective reader study.
- Compare the effect of softcopy vs printed film display on the diagnostic performance of digital mammography through a retrospective reader study.
- Compare the effect of breast density on the diagnostic accuracy of digital mammography vs screen-film mammography through a retrospective reader study.
- Compare the image quality and breast radiation dose in digital vs screen-film mammography in these participants.
- Determine the temporal variations in image quality, breast radiation dose, and other quality control parameters in the participating study centers.
OUTLINE: This is a randomized, multicenter study. Participants with postitive screening results are stratified according to age (under 50 vs 50-59 vs 60-70 vs over 70). Participants are randomized to one of two treatment arms.
- Arm I: Participants undergo a two-view screen-film mammogram followed by a two-view digital mammogram of each breast.
- Arm II: Participants undergo a two-view digital mammogram followed by a two-view screen-film mammogram of each breast.
Quality of life is assessed before the screening mammogram in the first 800 women enrolled. In an additional 1,200 participants (600 with positive screening results and 600 with negative screening results), quality of life is assessed shortly after the screening mammogram and at 1 year.
Participants are followed at 1 year with a repeat screen-film or digital mammogram.
PROJECTED ACCRUAL: A total of 49,500 participants (24,750 per arm) will be accrued for this study within 18 months.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SFM then FFDM | Other | Diagnostic Test: Full Field Digital Mammography, Diagnostic Test: Screen Film MammographyScreen Film Mammography (SFM) followed by Full Field Digital Mammography (FFDM) |
| FFDM then SFM | Other | Diagnostic Test: Full Field Digital Mammography, Diagnostic Test: Screen Film MammographyFull Field Digital Mammography (FFDM) followed by Screen Film Mammography (SFM) |
Who may qualify
- Ages
- Up to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Field Digital MammographyAlso: FFDM, Digital MammographyRadiologic test to screen women for Breast cancer using digital detectors | Diagnostic test | FFDM then SFM, SFM then FFDM |
| Screen Film MammographyAlso: SFM, Plain Film MamographyRadiologic test to screen women for Breast cancer using plain film detectors a resolution screen | Diagnostic test | FFDM then SFM, SFM then FFDM |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Background: PubMed 20093597Hendrick 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.
- Background: PubMed 18166758Tosteson 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.
- Results publication: PubMed 21502382Baum 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.
- Results publication: PubMed 18372463Hendrick 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.
- Results publication: PubMed 18227537Pisano 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.
- Results publication: PubMed 16878575Bloomquist 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.
- Results publication: PubMed 16878576Yaffe 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.
- Results publication: PubMed 15961755Pisano 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.
- Results publication: PubMed 16169887Pisano 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etta Pisano, MD study chair
UNC Lineberger Comprehensive Cancer Center
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Field Digital Mammography and Screen Film Mammography in people with Breast Cancer, run by American College of Radiology Imaging Network at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00008346, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.