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| Name | Class |
|---|---|
| Hologic, Inc. | INDUSTRY |
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The purpose of this study is to compare the imaging performance of an investigational breast computed tomography (CT) scanner, built at UC Davis, with that of an FDA-Approved breast tomosynthesis scanner (capable of producing standard 2-D mammography and 3-D tomosynthesis images), built by Hologic, Incorporated, in a group of patients with suspected breast cancer.
The primary aim of this study is the comparison of Beta values of several different CT and Tomosynthesis views (Beta of CT Sagittal View, Beta of CT Coronal View, Beta of CT Axial View, Beta of Tomosynthesis Craniocaudal View, Beta of Tomosynthesis Medial Lateral Oblique View). Lower Beta values correspond to better image quality (less noise, increased cancer detection).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer Patients | Experimental | Tomosynthesis Breast Scanning is done and breast CT Scanning is done. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tomosynthesis Breast Scanning | Radiation | The breast is positioned and compressed the same way it is in a conventional mammogram using a compression paddle device. The subject will be instructed to hold their breath and not move during the 7- second 3-D tomosynthesis acquisition. The affected breast is positioned with MLO compression. The radiation dose levels for each scan are equivalent to mammography |
| Measure | Description | Time Frame |
|---|---|---|
| Beta of CT Coronal View | frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection). | Day 1 |
| Beta of CT Sagittal View | frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection). | Day 1 |
| Beta of CT Axial View | frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection). | Day 1 |
| Beta of Tomosynthesis Craniocaudal View | frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection). | Day 1 |
| Beta of Tomosynthesis Medial Lateral Oblique View | frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John M Boone, PhD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Breast Cancer Patients | Tomosynthesis Breast Scanning is done and breast CT Scanning is done. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Female participants over the age of 35 with suspected breast cancer
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| ID | Title | Description |
|---|---|---|
| BG000 | Breast Cancer Patients | Tomosynthesis Breast Scanning is done and breast CT Scanning is done. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Beta of CT Coronal View | frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection). | Participants with suspected breast cancer | Posted | Mean | Standard Deviation | power-law slope(B) | Day 1 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breast Cancer Patients | Tomosynthesis Breast Scanning is done and breast CT Scanning is done. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Brock Staff Research Associate | UC Davis | 916-734-3101 | jmbrock@ucdavis.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Breast CT Scanning | Radiation | CT scanning will be performed before and after I.V. iodine contrast injection. The subject will lie prone on a large table (which is covered by a foam pad), and she will place the breast to be scanned in a small hole in that tabletop. The hole is surrounded by a soft neoprene "hammock," which will allow the subject's entire upper torso to slump into the scan plane of the device. After positioning of the affected breast by a female mammography technologist, the subject will be instructed to hold their breath for 16 seconds and the pre-contrast scan will commence. There will be no breast compression. Other than the sound of the relatively noisy x-ray system in the room, the subject will not feel or sense any aspect of this scan. |
|
| Day 1 |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Primary | Beta of CT Sagittal View | frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection). | Participants with suspected breast cancer | Posted | Mean | Standard Deviation | power-law slope(B) | Day 1 |
|
|
|
| Primary | Beta of CT Axial View | frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection). | Participants with suspected breast cancer | Posted | Mean | Standard Deviation | power-law slope(B) | Day 1 |
|
|
|
| Primary | Beta of Tomosynthesis Craniocaudal View | frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection). | Participants with suspected breast cancer | Posted | Mean | Standard Deviation | power-law slope(B) | Day 1 |
|
|
|
| Primary | Beta of Tomosynthesis Medial Lateral Oblique View | frequency range corresponding to noise power spectrum (NPS) where beta = NPS(f) = af^-B. beta is calculated as noise corresponding to frequency. The values of the exponent, beta, range from 1.5 to 3.5 Lower Beta values correspond to better image quality (less noise, increased cancer detection). | Participants with suspected breast cancer | Posted | Mean | Standard Deviation | power-law slope(B) | Day 1 |
|
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|
| 0 |
| 23 |
| 0 |
| 23 |
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| D017437 |
| Skin and Connective Tissue Diseases |