Ignite Creation Date:
2024-05-05 @ 11:03 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01248546
Status:
UNKNOWN
Last Update Posted:
2013-02-05
First Post:
2010-11-24
Brief Title:
Tomosynthesis in the Oslo Breast Cancer Screening Program
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Digital Breast Tomosynthesis in the Oslo Mammography Screening Program
Status:
UNKNOWN
Status Verified Date:
2013-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
DBT
Brief Summary:
The Digital Breast Tomosynthesis DBT in the Oslo Mammography Screening Program will include women aged 50 to 69 years invited to the population-based mammography-screening program All women attending the screening unit will be asked if they want to attend the trial If so they will be informed about the project the technique and the additional compression and radiation dose All mammographic examinations of women attending the trial will be independently interpreted by four radiologists Since the trial is part of the official Norwegian Breast Cancer Screening Program NBCSP the interpretations will be carried out on-line into the national screening database of the NBCSP The study will include independent reading of conventional digital 2D mammograms 2D plus computer-aided detection CAD 2D plus DBT and synthetic 2D plus DBT There will be a common consensus meeting for all examinations having a positive score Recalls and diagnostic work-up will be according to daily practice at the Oslo University Hospital Ullevaal and the guidelines of the NBCSP
Outcome measures will use performance indicators for organized screening programs including recall rate false positive scores cancer detection rate positive predictive values and cancer characteristics for the individual readers of the trial
Outcome measures will use performance indicators for organized screening programs including recall rate false positive scores cancer detection rate positive predictive values and cancer characteristics for the individual readers of the trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None