Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00267449
Status:
UNKNOWN
Last Update Posted:
2007-09-11
First Post:
2005-12-19
Brief Title:
Adjunctive Efficacy Study Of The SoftScan Optical Breast Imaging System
Sponsor:
ART Advanced Research Technologies Inc
Organization:
ART Advanced Research Technologies Inc
Study Overview
Official Title:
Adjunctive Efficacy Study Of The SoftScan Optical Breast Imaging System
Status:
UNKNOWN
Status Verified Date:
2007-09
Last Known Status:
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:
None
Brief Summary:
The primary study endpoint -SoftScan adjunctive accuracy- will be used to test the hypothesis that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy that is significantly better than x-ray mammography alone
Detailed Description:
Prospective serially-recruited blinded and unblinded validation study to test that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy that is significantly better than x-ray mammography alone Healthy volunteers and patients scheduled for tissue biopsyexcision of a suspicious breast lesion will be enrolled Reader Studies will be performed in which interpreting investigators will perform blinded mammography interpretations and reinterpretations of mammography and SoftScan interpretations Diagnostic accuracy will be calculated using tissue histopathology as the reference standard
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