Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008346
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2001-01-06
Brief Title:
Digital Mammography Screening Trial ACRIN6652
Sponsor:
American College of Radiology Imaging Network
Organization:
American College of Radiology Imaging Network
Study Overview
Official Title:
Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DMIST
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
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 manufacturers 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 1200 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 49500 participants 24750 per arm will be accrued for this study within 18 months
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 manufacturers 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 1200 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 49500 participants 24750 per arm will be accrued for this study within 18 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ACRIN-6652 | OTHER | None | None |
| U01CA080098 | NIH | None | None |
| U01CA079778 | NIH | American College of Radiology | httpsreporternihgovquickSearchU01CA079778 |