Computed TomographyChrysalisNCT01261559
Breast Displacement and CT Radiation Dose
A study testing Chrysalis breast displacement device in people with Computed Tomography and Radiation Dosage, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Computed Tomography, Radiation Dosage
- What is being tested?
- Chrysalis breast displacement device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Feb 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- scheduled for CT of the abdomen and pelvis at Harborview Medical Center
- able to provide written informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: 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.
Read the 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.
- Conditions
- Computed Tomography, Radiation Dosage
- Being tested
- Chrysalis breast displacement device
- Keywords
- Computed tomography, Radiation dose, Dose reduction, Breast displacement, Chrysalis device, Image quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Chrysalis breast displacement device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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
Measured: two months
Number of Participants With Presence of Artifacts Based on CT Image Quality
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.
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Computed TomographyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Kalsch Sandstrom, University of Washington
- Investigators
- Claire K Sandstrom, MD, Principal investigator, University of Washington Department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261559
- Sponsor's protocol ID
- 39071
- Acronym
- Chrysalis
- Status last verified
- Jun 2018
- First submitted
- 8 Dec 2010
- Last updated
- 6 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20008689Smith-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.
PubMed 20008690Hurwitz 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.
PubMed 16714665Parker 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.
PubMed 16247139Pajor 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.
PubMed 1841487Yilmaz 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.
PubMed 17259846Kang 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.
PubMed 18345348
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Displacement During Computed Tomography on Breast Radiation Dose and Image Quality
- ClinicalTrials.gov ID
- NCT01261559
- Acronym / sponsor ID
- Chrysalis / 39071
- Conditions
- Computed Tomography, Radiation Dosage
- Keywords
- Computed tomography, Radiation dose, Dose reduction, Breast displacement, Chrysalis device, Image quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Posted 5 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Chrysalis breast displacement deviceWomen 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- scheduled for CT of the abdomen and pelvis at Harborview Medical Center
- able to provide written informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chrysalis breast displacement deviceChrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement. | Device | Chrysalis CT |
Primary outcome
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.
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.
2 secondary outcomes
CT Image Noise
Time frame: two months
Number of Participants With Presence of Artifacts Based on CT Image Quality
Time frame: two months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20008689Berrington 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.
- Background: PubMed 20008690Smith-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.
- Background: PubMed 16714665Hurwitz 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.
- Background: PubMed 16247139Parker 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.
- Background: PubMed 1841487Pajor 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.
- Background: PubMed 17259846Yilmaz 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.
- Background: PubMed 18345348Kang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire K Sandstrom, MD principal investigator
University of Washington Department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chrysalis breast displacement device in people with Computed Tomography and Radiation Dosage, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01261559, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.