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:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cks13@uw.edu', 'phone': '206-744-3561', 'title': 'Dr. Claire Sandstrom', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'from time potential subject was approached about possible enrollment to the time when the device and TLDs were removed.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard CT', 'description': 'Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Chrysalis CT', 'description': '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.', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Skin Entrance Radiation Dose During Computed Tomography (CT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard CT', 'description': 'Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.'}, {'id': 'OG001', 'title': 'Chrysalis CT', 'description': '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.'}], 'classes': [{'title': 'Mean entrance skin dose at inframammary fold', 'categories': [{'measurements': [{'value': '1775', 'spread': '1634', 'groupId': 'OG000'}, {'value': '1325', 'spread': '1158', 'groupId': 'OG001'}]}]}, {'title': 'Mean breast entrance skin dose (average TLD2-4)', 'categories': [{'measurements': [{'value': '625', 'spread': '677', 'groupId': 'OG000'}, {'value': '259', 'spread': '334', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour', 'description': "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.", 'unitOfMeasure': 'mrad', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Relative Skin Entrance Radiation Dose in % During Computed Tomography (CT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard CT', 'description': 'Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.'}, {'id': 'OG001', 'title': 'Chrysalis CT', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '30', 'groupId': 'OG000'}, {'value': '36', 'spread': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.2', 'ciLowerLimit': '4', 'ciUpperLimit': '25', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '10', 'groupDescription': 'Powered to detect difference of 10% at 80% power if 66 or more subjects enrolled.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'A multivariate linear regression model was fitted for the main outcome of percent relative dose, with age, BMI, and bra cup size as covariates.'}], 'paramType': 'MEAN', 'timeFrame': 'from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour', 'description': "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.", 'unitOfMeasure': 'percentage of dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CT Image Noise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard CT', 'description': 'Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.'}, {'id': 'OG001', 'title': 'Chrysalis CT', 'description': '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.\n\nChrysalis breast displacement device: Chrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement.'}], 'classes': [{'title': 'Liver dome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.1', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Spleen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.2', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '21.1', 'spread': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Kidney', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.8', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '24.5', 'spread': '6.8', 'groupId': 'OG001'}]}]}, {'title': 'Aorta (without mixing artifact)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '21.1', 'spread': '7.26', 'groupId': 'OG001'}]}]}, {'title': 'IVC (without mixing artifact)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.1', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Retroperitoneal fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.4', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'Subcutaneous fat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.3', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '12.9', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Medullary Bone of Spine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.2', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '18.2', 'groupId': 'OG001'}]}]}, {'title': 'Paraspinal muscle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.8', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Breast (if imaged)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.0', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '26.1', 'spread': '11.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'two months', 'description': '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.\n\nHU 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', 'unitOfMeasure': 'Hounsfield units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'In some cases, a reliable measurement of noise could not be measured on the location. For example, if the breast was not included on the CT, breast noise could not be measured (12 controls and 21 Chrysalis). Too little retroperitoneal or subcutaneous fat was present to draw the relevant ROI in 1 control and 1 Chrysalis subject, respectively.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Presence of Artifacts Based on CT Image Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard CT', 'description': 'Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.'}, {'id': 'OG001', 'title': 'Chrysalis CT', 'description': '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.\n\nChrysalis breast displacement device: Chrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'two months', 'description': '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.\n\nTo 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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard CT', 'description': 'Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.'}, {'id': 'FG001', 'title': 'Chrysalis CT', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment: December 2010 to February 2012, at Harborview Medical Center (inpatient wards, outpatient clinics, and emergency departments)', 'preAssignmentDetails': 'All women who were approached for the study were screened for exclusion criteria prior to enrollment.\n\n110 eligible patients were approached, and 37 declined participation or met exclusion criteria. 1 subject was scanned but TLD readings were clearly erroneous and were therefore excluded. 72 subjects were ultimately included in analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard CT', 'description': 'Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.'}, {'id': 'BG001', 'title': 'Chrysalis CT', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'spread': '12.9', 'groupId': 'BG000'}, {'value': '40.3', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '40.3', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-07', 'studyFirstSubmitDate': '2010-12-08', 'resultsFirstSubmitDate': '2013-06-18', 'studyFirstSubmitQcDate': '2010-12-14', 'lastUpdatePostDateStruct': {'date': '2018-07-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-08-30', 'studyFirstPostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin Entrance Radiation Dose During Computed Tomography (CT)', 'timeFrame': 'from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour', 'description': "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."}, {'measure': 'Relative Skin Entrance Radiation Dose in % During Computed Tomography (CT)', 'timeFrame': 'from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'CT Image Noise', 'timeFrame': 'two months', 'description': '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.\n\nHU 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'}, {'measure': 'Number of Participants With Presence of Artifacts Based on CT Image Quality', 'timeFrame': 'two months', 'description': '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.\n\nTo 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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Computed tomography', 'Radiation dose', 'Dose reduction', 'Breast displacement', 'Chrysalis device', 'Image quality'], 'conditions': ['Computed Tomography', 'Radiation Dosage']}, 'referencesModule': {'references': [{'pmid': '20008689', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20008690', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16714665', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '16247139', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '1841487', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '17259846', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18345348', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nA device called Chrysalis has been designed and received FDA approval for the purposes of displacing female breast tissue during CT.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* scheduled for CT of the abdomen and pelvis at Harborview Medical Center\n* able to provide written informed consent\n\nExclusion Criteria:\n\n* Inability to provide written consent for self (minor, intubated, sedated, mentally incapacitated, in excessive physical distress)\n* Chest or breast surgery within the previous 8 weeks\n* Breast implants\n* Open wounds to the chest wall\n* Fractures of the ribs or spine within the previous 3 months\n* Patients requiring oxygen therapy\n* Mastectomy\n* Breast radiation therapy\n* Scarring to the breasts which would prevent displacement\n* Claustrophobia is not an absolute exclusion criterion, but patient comfort will be a primary concern.'}, 'identificationModule': {'nctId': 'NCT01261559', 'acronym': 'Chrysalis', 'briefTitle': 'Breast Displacement and CT Radiation Dose', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Effect of Displacement During Computed Tomography on Breast Radiation Dose and Image Quality', 'orgStudyIdInfo': {'id': '39071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard CT', 'description': 'Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.'}, {'type': 'EXPERIMENTAL', 'label': 'Chrysalis CT', 'description': '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.', 'interventionNames': ['Device: Chrysalis breast displacement device']}], 'interventions': [{'name': 'Chrysalis breast displacement device', 'type': 'DEVICE', 'description': 'Chrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement.', 'armGroupLabels': ['Chrysalis CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Claire K Sandstrom, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington Department of Radiology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow, Section of Emergency Radiology, Department of Radiology', 'investigatorFullName': 'Claire Kalsch Sandstrom', 'investigatorAffiliation': 'University of Washington'}}}}