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  • The VICTRE Trial: Open-Source, In-Silico Clinical Trial For Evaluating Digital Breast Tomosynthesis (VICTRE)

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Summary

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.

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.

Excerpt

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.  

 

Localtab Group


Localtab
activetrue
titleData Access

Data Access

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Click the Versions tab for more info about data releases.


Localtab
titleDetailed Description

Detailed Description

Collection Statistics

Updated 2017/05/01

Modalities

FFDM, DBT

Number of Patients


Number of Studies


Number of Series


Number of Images


Image Size (GB)

Supporting Documentation and Metadata



Localtab
titleCitations & Data Usage Policy

Citations & Data Usage Policy 

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.

Please be sure to include the following citations in your work if you use this data set:

Info
titleDataset Citation

Badano A, Graff CG, Badal A, Sharma D, Zeng R, Samuelson FW, Glick S, Myers KJ. The VICTRE Trial: Open-Source, In-Silico Clinical Trial for Evaluating Digital Breast Tomosynthesis. 2018.


Info
titlePublication Citation

(2018) doi: (Coming Soon)


Info
titleTCIA Citation

Clark K, Vendt B, Smith K, Freymann J, Kirby J, Koppel P, Moore S, Phillips S, Maffitt D, Pringle M, Tarbox L, Prior F. The Cancer Imaging Archive (TCIA): Maintaining and Operating a Public Information Repository, Journal of Digital Imaging, Volume 26, Number 6, December, 2013, pp 1045-1057. (paper)

 

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Localtab
titleVersions

Version 1 (Current): Updated 2017/07/28