Clinical trials and clinical studies are expensive and time consuming. This is problematic for developing new imaging technology and imaging biomarkers. The development of an imaging technology or biomarker may involve optimizing many parameters simultaneously, and thus it is not practical to do so using a clinical trial, even though ultimately, the new technology or biomarker must be evaluated through a clinical trial.
It is now possible to simulate individuals and specific pathologies from the population of all humans with increasingly higher accuracy. This, together with advanced models of image simulation, image processing and image reconstruction, means that we can create arbitrarily large databases of simulated images. By combining these advances with advances in model observer methods, it is both possible and useful to conduct virtual clinical trials for optimization and for estimating the impact of a new imaging technology. Using a series of linked simulations, the impact of each step in the entire imaging chain from biology to study result can be evaluated.
We define a virtual clinical trial as a combination of the following steps: (1) establish ground truth, (2) forward model the image generation, (3) apply model observers, and (4) analyze the imaging results against the ground truth. Each step has a series of sub-components that require individual simulations; each simulation has uncertainties or parameter variations that must be taken into account. While this is a nascent field, there have been an increasing number of studies as well as short courses in different medical imaging subfields (i.e., Mammography, CT , PET).
The goal of this JMI special section is to pull together recent research on virtual clinical trials from different medical imaging subfields to illustrate both progress and commonalities.
This JMI special is open to everyone, and especially encourages relevant submissions for (but not limited to) the following topics:
- Review articles
- Specific medical imaging subfield research (i.e. mammography, CT, PET)
- Metrics and standards for reporting
- Variability in the biological/patient, acquisition, image reconstruction, processing, and interpretation components
- Pipelines for processing
- Computation aspects
Manuscripts should conform to the author guidelines of the Journal of Medical Imaging. Prospective authors should submit an electronic copy of their manuscript through the online submission system at https://jmi.msubmit.net. The special section should be mentioned in the cover letter. Each manuscript will be reviewed by at least two independent reviewers. Peer review will commence immediately upon manuscript submission, with a goal of making a first decision within six weeks. Special sections are opened online once a minimum of four papers have been accepted; each paper is published as soon as the copyedited and typeset proofs are approved by the author.
NOTE: Publication is currently in progress for this special section of Volume 7, Issue 4.