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Expensive and lengthy clinical trials delay regulatory evaluation of innovative medical technologies affecting patient access to high-quality medical products. Sophisticated simulation tools are increasingly being used in device development, but are rarely used in regulatory applications. We investigate a new paradigm for evaluating digital breast tomosynthesis (DBT) as a replacement for digital mammography (DM), using exclusively in-silico methods. A total of 2986 subjects, with breast sizes and radiographic densities representative of a screening population and compressed thicknesses from 3.5 to 6 cm, were simulated and imaged on in-silico versions of DM and DBT systems using fast Monte Carlo x-ray transport. Images were interpreted by a computational reader detecting the presence of lesions. The in-silico trial (VICTRE) was designed to replicate a comparative trial from a previous regulatory submission. The endpoint was the difference in area under the receiver-operating-characteristic curve between modalities (delta-AUC) for lesion detection. Using a fully-crossed design, VICTRE was sized for a standard error (SE) of 0.01 in delta-AUC, half the uncertainty seen in the comparative trial. |
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A 1-hour summary presentation of the project and findings was given at the FDA Grand Rounds on 3/14/2019 and can be found here. A systematic exploration of the trial parameters including lesion types and sizes is also possible and greatly facilitated by the availability of open-source, free software tools available at https://github.com/DIDSR/VICTRE. |
Expensive and lengthy clinical trials delay regulatory evaluation of innovative medical technologies affecting patient access to high-quality medical products. Sophisticated simulation tools are increasingly being used in device development, but are rarely used in regulatory applications. We investigate a new paradigm for evaluating digital breast tomosynthesis (DBT) as a replacement for digital mammography (DM), using exclusively in-silico methods.
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Researchers studying radiomics will be able to evaluate features for robustness across a variety of scanners. Features can be calculated using the researchers own software or third party software such as IBEX (imaging biomarker explorer). Related publications: http://journals.lww.com/investigativeradiology/Abstract/2015/11000/Measuring_Computed_Tomography_Scanner_Variability.3.aspx The following paper was generated on different imaging modalities but the same phantom, this is a related but independent paper with a different set of authors: http://tinyurl.com/zm7tr7p |
This data set was provided to TCIA by Authors: Mackin, Dennis; Fave, Xenia; Zhang, Lifei; Fried, David; Yang, Jinzhong; Taylor, Brian; Rodriguez-Rivera, Edgardo; Dodge, Cristina; Jones, Aaron Kyle; and Court, Laurence.
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title | Detailed Description |
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Detailed Description
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Collection Statistics
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Updated 2017/05/01
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Modalities
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Number of Patients
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Number of Studies
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Number of Series
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Number of Images
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Supporting Documentation and Metadata
Acquisition parameters for the phantom scans in this Collection:
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Scan
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Manufacturer
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Model
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Kernel
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Type
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Slice Thickness (mm)
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Pixel (mm)
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Spiral Pitch Factor
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kVp
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Effective mAs
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CTDIvol (mGy)
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CCR1-GE1
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GE
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Discovery CT750 HD
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standard
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helical
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2.5
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0.49
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0.98
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120
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81
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6.19
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CCR1-GE2
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GE
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Discovery CT750 HD
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standard
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axial
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2.5
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0.70
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1.00
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120
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300
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CCR1-GE3
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GE
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Discovery CT750 HD
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standard
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helical
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2.5
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0.78
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0.98
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120
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122
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9.3
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CCR1-GE4
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GE
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Discovery ST
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standard
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helical
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2.5
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0.98
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1.35
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120
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143
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16.3
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CCR1-GE5
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GE
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LightSpeed RT
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standard
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helical
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2.5
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0.98
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0.75
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120
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1102
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53.6
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CCR1-GE6
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GE
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LightSpeed RT16
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standard
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helical
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2.5
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0.98
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0.94
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120
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367
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18.8
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CCR1-GE7
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GE
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LightSpeed VCT
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standard
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helical
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2.5
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0.74
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0.98
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120
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82
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CCR1-P1
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Philips
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Brilliance Big Bore
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B
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helical
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3.0
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0.98
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0.94
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120
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320
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17.8
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CCR1-P2
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Philips
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Brilliance Big Bore
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C
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helical
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3.0
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0.98
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0.94
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120
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369
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15.8
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CCR1-P3
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Philips
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Brilliance Big Bore
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B
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helical
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3.0
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1.04
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0.81
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120
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320
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19.9
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CCR1-P4
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Philips
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Brilliance Big Bore
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B
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helical
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3.0
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1.04
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0.81
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120
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369
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19.9
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CCR1-P5
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Philips
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Brilliance 64
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B
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helical
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3.0
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0.98
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0.67
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120
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372
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16.4
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CCR1-S1
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Siemens
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Sensation Open
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B31s
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axial
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3.0
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0.54
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1.00
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120
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26 - 70
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1.5
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CCR1-S2
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Siemens
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SOMATOM Definition Flash
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['I70f', '2']
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helical
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2.0
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0.52
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0.60
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120
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17 - 28
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CCR1-T1
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Toshiba
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Aquilion
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FC18
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helical
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3.0
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0.63
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1.11
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120
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135
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4.0
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CCR1-T2
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Toshiba
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Aquilion
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FC18
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helical
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3.0
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0.63
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1.11
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120
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135
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3.8
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CCR1-T3
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Toshiba
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Aquilion ONE
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FC18
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helical
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3.0
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0.98
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0.99
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120
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151
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13.5
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This collection is freely available to browse, download, and use for commercial, scientific and educational purposes as outlined in the Creative Commons Attribution 3.0 Unported License. See TCIA's Data Usage Policies and Restrictions for additional details. Questions may be directed to help@cancerimagingarchive.net.
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