Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-26 @ 1:33 PM
Study NCT ID:
NCT01261559
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2010-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Breast Displacement and CT Radiation Dose
Sponsor:
University of Washington
Organization:
Study Overview
Official Title:
Effect of Displacement During Computed Tomography on Breast Radiation Dose and Image Quality
Status:
COMPLETED
Status Verified Date:
2018-06
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:
Chrysalis
Brief Summary:
The primary hypothesis of this study is that breast displacement out of the direct plane of imaging during computed tomography (CT) of the abdomen will reduce effective radiation dose to the female breast. Secondary hypotheses are that image noise and artifacts will also be decreased.
Detailed Description:
Computed tomography (CT) is a significant source of medical-related radiation, and radiation-related cancer risk is increasingly recognized in the medical and lay community. One of the groups at greatest risk for radiation-induced malignancies is young females due to the radiosensitivity of female breast tissue. Breast tissue frequently lies within the imaging plane for CT of the abdomen with limited gain in diagnostic information. We propose displacing this breast tissue out of the direct imaging plane will decrease unnecessary radiation exposure and may also indirectly improve image quality.
A device called Chrysalis has been designed and received FDA approval for the purposes of displacing female breast tissue during CT.
A device called Chrysalis has been designed and received FDA approval for the purposes of displacing female breast tissue during CT.
Study Oversight
Has Oversight DMC:
False
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?: