Breast Displacement and CT Radiation Dose - Full Text View

Purpose

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.

Condition	Intervention
Computed Tomography Radiation Dosage	Device: Chrysalis breast displacement device

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Effect of Displacement During Computed Tomography on Breast Radiation Dose and Image Quality

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Noise

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Skin entrance radiation dose during CT [ Time Frame: two months (subjects will be enrolled over 2 months; they will undergo a single CT and will not be followed for any length of time. ] [ Designated as safety issue: No ]
Skin entrance radiation doses will be measured with TLDs affixed to the subject's breast during CT of the abdomen. TLDs will then be submitted to Landaeur for measurement.

Secondary Outcome Measures:

CT image noise and image quality [ Time Frame: two months ] [ Designated as safety issue: No ]
CT images acquired will be reviewed for the presence of artifacts and interrogated for image noise

Enrollment:	73
Study Start Date:	December 2010
Study Completion Date:	February 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Detailed Description:

Computed tomography 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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261559

Locations

United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104

Sponsors and Collaborators

University of Washington

Investigators

Principal Investigator:

Claire K Sandstrom, MD

University of Washington Department of Radiology

More Information

Publications:

Berrington de González 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.

Smith-Bindman R, Lipson J, Marcus R, Kim KP, Mahesh M, Gould R, Berrington de González 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.

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.

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.

Pajor L, Kálmán E, Köszegi 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, Ya?ar D, Ozer H, Adaletli I, Selçuk D, Akman C, Altu? 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.

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.

Responsible Party:	Claire Kalsch Sandstrom, Fellow, Section of Emergency Radiology, Department of Radiology, University of Washington
ClinicalTrials.gov Identifier:	NCT01261559 History of Changes
Other Study ID Numbers:	39071-B
Study First Received:	December 8, 2010
Last Updated:	July 23, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

Computed tomography
Radiation dose
Dose reduction

Breast displacement
Chrysalis device
Image quality

ClinicalTrials.gov processed this record on May 21, 2013

Breast Displacement and CT Radiation Dose (Chrysalis)