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

December 8, 2010
August 30, 2013
December 2010
February 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
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.
Complete list of historical versions of study NCT01261559 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Breast Displacement and CT Radiation Dose
Effect of Displacement During Computed Tomography on Breast Radiation Dose and Image Quality

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Computed Tomography
  • Radiation Dosage
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.
  • 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.
    Intervention: Device: Chrysalis breast displacement device

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01261559
39071-B
No
Claire Kalsch Sandstrom, University of Washington
University of Washington
Not Provided
Principal Investigator: Claire K Sandstrom, MD University of Washington Department of Radiology
University of Washington
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP