Breast Displacement and CT Radiation Dose (Chrysalis)
|ClinicalTrials.gov Identifier: NCT01261559|
Recruitment Status : Completed
First Posted : December 16, 2010
Results First Posted : November 5, 2013
Last Update Posted : December 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Computed Tomography Radiation Dosage||Device: Chrysalis breast displacement device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Displacement During Computed Tomography on Breast Radiation Dose and Image Quality|
|Study Start Date :||December 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
No Intervention: Standard CT
Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
Experimental: Chrysalis CT
Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
Device: Chrysalis breast displacement device
Chrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement.
- Skin Entrance Radiation Dose During Computed Tomography (CT) [ Time Frame: from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour ]Skin entrance radiation doses will be measured with Thermoluminescent dosimeters (TLDs) affixed to the subject's chest and breast during CT of the abdomen. TLD #1 is at the inframammary fold, serving as internal control for each subject. Three additional TLDs (#2-4) are affixed to the subject's breast at 3 pre-ascribed locations. The same is done for the right and left breasts (8 TLDs total). TLDs will then be submitted to Landaeur for measurement.
- Relative Skin Entrance Radiation Dose in % During Computed Tomography (CT) [ Time Frame: from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour ]Relative skin entrance dose at the breast (group mean of patient's average skin entrance dose at TLDs 2-4) divided by skin entrance dose at the inframammary TLD (TLD 1) in %. For each patient, doses at TLDs 2-4 were averaged, and then the group mean of this was divided by the group mean at the inframammary TLD, then multiplied by 100 to get % dose. A relative dose of 20% means that the skin entrance dose at the breast was 20% of the skin entrance dose at the inframammary fold.
- CT Image Noise and Image Quality [ Time Frame: two months ]CT images acquired will be reviewed for the presence of artifacts and interrogated for image noise
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261559
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Claire K Sandstrom, MD||University of Washington Department of Radiology|