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
  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:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.


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: 72
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 (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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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
Results First Received: June 18, 2013
Last Updated: August 30, 2013
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 August 20, 2014