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Completed

NCT Number: NCT01261559

Breast Displacement and CT Radiation Dose

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.

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Key information

Conditions

Computed Tomography Radiation Dosage

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Harborview Medical Center

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chrysalis breast displacement device

Device

Chrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement.

Primary outcomes

  1. 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

    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.

  2. 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

    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 outcomes

  1. CT Image Noise

    Time frame: two months

    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.

    HU 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

  2. Number of Participants With Presence of Artifacts Based on CT Image Quality

    Time frame: two months

    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.

    To 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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Effect of Displacement During Computed Tomography on Breast Radiation Dose and Image Quality

Acronym: Chrysalis

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 16, 2010
Registry last updated
Jul 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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