Breast Displacement and CT Radiation Dose (Chrysalis)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claire Kalsch Sandstrom, University of Washington
ClinicalTrials.gov Identifier:
NCT01261559
First received: December 8, 2010
Last updated: August 30, 2013
Last verified: August 2013
Results First Received: June 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Conditions: Computed Tomography
Radiation Dosage
Intervention: Device: Chrysalis breast displacement device

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment: December 2010 to February 2012, at Harborview Medical Center (inpatient wards, outpatient clinics, and emergency departments)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

All women who were approached for the study were screened for exclusion criteria prior to enrollment.

110 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.


Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Standard CT     Chrysalis CT  
STARTED     36     36  
COMPLETED     36     36  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Standard CT     Chrysalis CT     Total  
Number of Participants  
[units: participants]
  36     36     72  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     36     36     72  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  40.2  ± 12.9     40.3  ± 12.8     40.3  ± 12.8  
Gender  
[units: participants]
     
Female     36     36     72  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     36     36     72  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   CT Image Noise and Image Quality   [ Time Frame: two months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Claire Sandstrom
Organization: University of Washington
phone: 206-744-3561
e-mail: cks13@uw.edu


Publications:


Responsible Party: Claire Kalsch Sandstrom, University of Washington
ClinicalTrials.gov Identifier: NCT01261559     History of Changes
Other Study ID Numbers: 39071-B
Study First Received: December 8, 2010
Results First Received: June 18, 2013
Last Updated: August 30, 2013
Health Authority: United States: Institutional Review Board