Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373354
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-15
Brief Title:
Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
To compare narrow-angle digital breast tomosynthesis DBT and wide-angle DBT
Detailed Description:
Primary Objectives
- The primary objective of this proposed study is to show that iWBT investigational wide-angle breast tomosynthesis images provide better lesion conspicuity for masses and architectural distortions than NBT images based on the standard screening tomosynthesis imaging
Secondary Objectives
The secondary objective of this proposed study is to show that WBT images provide better lesion conspicuity for masses and architectural distortions based on the standard screening tomosynthesis imaging
Additional secondary objectives include radiologist feedback on the iWBT images technologist experience with iWBT and a participant comfort survey
- The primary objective of this proposed study is to show that iWBT investigational wide-angle breast tomosynthesis images provide better lesion conspicuity for masses and architectural distortions than NBT images based on the standard screening tomosynthesis imaging
Secondary Objectives
The secondary objective of this proposed study is to show that WBT images provide better lesion conspicuity for masses and architectural distortions based on the standard screening tomosynthesis imaging
Additional secondary objectives include radiologist feedback on the iWBT images technologist experience with iWBT and a participant comfort survey
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03341 | OTHER | NCI-CTRP Clinical Registry | None |