NCT01261559

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 5, 2013

Completed
Last Updated

July 6, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

December 8, 2010

Results QC Date

June 18, 2013

Last Update Submit

June 7, 2018

Conditions

Computed TomographyRadiation Dosage

Keywords

Computed tomographyRadiation doseDose reductionBreast displacementChrysalis deviceImage quality

Outcome Measures

Primary Outcomes (2)

  • Skin Entrance Radiation Dose During Computed Tomography (CT)

    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.

    from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour

  • Relative Skin Entrance Radiation Dose in % During Computed Tomography (CT)

    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.

    from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour

Secondary Outcomes (2)

  • CT Image Noise

    two months

  • Number of Participants With Presence of Artifacts Based on CT Image Quality

    two months

Study Arms (2)

Standard CT

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

Chrysalis breast displacement deviceDEVICE

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

Chrysalis CT

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • scheduled for CT of the abdomen and pelvis at Harborview Medical Center
  • able to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (7)

  • 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: 20008689BACKGROUND

  • 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: 20008690BACKGROUND

  • 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: 16714665BACKGROUND

  • 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: 16247139BACKGROUND

  • 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: 1841487BACKGROUND

  • 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: 17259846BACKGROUND

  • 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.

    PMID: 18345348BACKGROUND

Results Point of Contact

Title
Dr. Claire Sandstrom
Organization
University of Washington
cks13@uw.edu
206-744-3561

Study Officials

  • Claire K Sandstrom, MD

    University of Washington Department of Radiology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow, Section of Emergency Radiology, Department of Radiology

Study Record Dates

First Submitted

December 8, 2010

First Posted

December 16, 2010

Study Start

December 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

July 6, 2018

Results First Posted

November 5, 2013

Record last verified: 2018-06

Locations

US(1)