Ignite Creation Date:
2025-12-18 @ 4:02 AM
Ignite Modification Date:
2025-12-23 @ 9:56 PM
Study NCT ID:
NCT00763100
Status:
None
Last Update Posted:
2011-01-06 00:00:00
First Post:
2008-09-26 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Tomosynthesis in the BIRADS 3 Population
Sponsor:
None
Organization:
Study Overview
Official Title:
The Efficacy of Tomosynthesis in the BIRADS 3 Population Including Surveillance of Patients in the Treatment or Post-Treatment for Breast Cancer
Status:
None
Status Verified Date:
2011-01
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:
BIRADS
Brief Summary:
There are three main objectives, centering on those patients targeted for surveillance imaging. The first objective is to compare image quality and specificity of breast tomosynthesis and conventional 2D mammography in a BIRADS 3 diagnostic population. The second objective is to compare image quality and ability to determine post-surgical and post-radiation changes from recurrence in a post-cancer subset of a BIRADS 3 population having undergone conservation therapy (lumpectomy with or without radiation. The final objective is to compare image quality and the ability to determine chemoresponsiveness in a post-cancer subset of a BIRADS 3 population, who are undergoing neoadjuvant chemotherapy.
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?: