- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01261559
Breast Displacement and CT Radiation Dose (Chrysalis)
Effect of Displacement During Computed Tomography on Breast Radiation Dose and Image Quality
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98104
- Harborview Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- scheduled for CT of the abdomen and pelvis at Harborview Medical Center
- able to provide written informed consent
Exclusion Criteria:
- Inability to provide written consent for self (minor, intubated, sedated, mentally incapacitated, in excessive physical distress)
- Chest or breast surgery within the previous 8 weeks
- Breast implants
- Open wounds to the chest wall
- Fractures of the ribs or spine within the previous 3 months
- Patients requiring oxygen therapy
- Mastectomy
- Breast radiation therapy
- Scarring to the breasts which would prevent displacement
- Claustrophobia is not an absolute exclusion criterion, but patient comfort will be a primary concern.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Chrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour
|
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.
|
from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CT Image Noise
Time Frame: two months
|
To evaluate image noise, mean of the Standard deviation (SD) of the pixel values, measured in Hounsfield units (HU), will be measured in Picture Archiving and Communication System (PACS) using a region of interest (ROI) measuring 90-110 mm^2 in size drawn over each of these body regions: hepatic dome, spleen, renal cortex, retroperitoneal fat, subcutaneous fat, paraspinal muscles, and if present, breast tissue, avoiding vascular structures in each case. SD for ROI measuring 90-110 mm^2 in size will also be drawn over the aorta and inferior vena cava (IVC), remote from contrast mixing artifact, and over medullary bone of the spine. HU is the linear scale by which digital image data are displayed in PACS and reflect relative attenuation compared to distilled water at a standard temperature and pressure (STP) (defined as 0 HU) and of pure air at STP (defined as -1000HU). Within a drawn ROI, the PACS will give the mean attenuation (in HU) and the standard deviation of HU (reflecting |
two months
|
Number of Participants With Presence of Artifacts Based on CT Image Quality
Time Frame: two months
|
CT images acquired will be reviewed for the presence of artifacts that might be attributed to the displacement device or to the presence of the breast tissue. To evaluate for artifacts, the exam will be qualitatively reviewed by a board certified radiologist for imaging artifacts, such as streak artifact. It will be noted on a per participant basis whether any imaging artifacts are identified. |
two months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Claire K Sandstrom, MD, University of Washington Department of Radiology
Publications and helpful links
General Publications
- Berrington de Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009 Dec 14;169(22):2071-7. doi: 10.1001/archinternmed.2009.440.
- Kang M, Ragan BG, Park JH. Issues in outcomes research: an overview of randomization techniques for clinical trials. J Athl Train. 2008 Apr-Jun;43(2):215-21. doi: 10.4085/1062-6050-43.2.215.
- Smith-Bindman R, Lipson J, Marcus R, Kim KP, Mahesh M, Gould R, Berrington de Gonzalez A, Miglioretti DL. Radiation dose associated with common computed tomography examinations and the associated lifetime attributable risk of cancer. Arch Intern Med. 2009 Dec 14;169(22):2078-86. doi: 10.1001/archinternmed.2009.427.
- Hurwitz LM, Yoshizumi TT, Reiman RE, Paulson EK, Frush DP, Nguyen GT, Toncheva GI, Goodman PC. Radiation dose to the female breast from 16-MDCT body protocols. AJR Am J Roentgenol. 2006 Jun;186(6):1718-22. doi: 10.2214/AJR.04.1917.
- Parker MS, Hui FK, Camacho MA, Chung JK, Broga DW, Sethi NN. Female breast radiation exposure during CT pulmonary angiography. AJR Am J Roentgenol. 2005 Nov;185(5):1228-33. doi: 10.2214/AJR.04.0770.
- Pajor L, Kalman E, Koszegi T. Cholesteryl hemisuccinate's inductive effect on membrane rigidization regarding both, its remodelling of the cells' surface receptor pattern and its decreasing the natural killer susceptibility of K-562 cells. Acta Biol Hung. 1991;42(4):371-83.
- Yilmaz MH, Albayram S, Yasar D, Ozer H, Adaletli I, Selcuk D, Akman C, Altug A. Female breast radiation exposure during thorax multidetector computed tomography and the effectiveness of bismuth breast shield to reduce breast radiation dose. J Comput Assist Tomogr. 2007 Jan-Feb;31(1):138-42. doi: 10.1097/01.rct.0000235070.50055.e6.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 39071
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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