The community of scientists and clinicians working to advance hyperpolarized (HP) gas magnetic resonance imaging (MRI) has long believed that its ability to image pulmonary function three-dimensionally, non-invasively, and in a single breath has enormous potential to advance pulmonary medicine. After all, the workhorse of this field is the pulmonary function test, which, invented in 1846, remains the oldest clinical diagnostic test still in use today . Yet, more than two decades after the first demonstration of HP gas MR images in humans , we are not exactly overrun by its widespread adoption. Of course, the technology has endured barriers associated with intellectual property rights and absence of regulatory approval, but these issues have now been addressed and phase III trials are expected to start in 2017. However, even if approval from the Food and Drug Administration were in hand today, barriers to dissemination remain to be conquered.
In this regard, we can learn much from the seminal high-tech marketing book by Geoffrey Moore, titled “Crossing the Chasm: Marketing and Selling Technology Products to Mainstream Customers” . Its thesis is that many novel technologies are quickly embraced by a few “early adopters,” but face a major gap in reaching a broader community of users. In the case of HP gas MRI, it must actually cross two chasms. The first is the technical one we have been crossing for years. HP gas imaging requires MRI to be conducted in ways not normally done—rapid scans of nuclei other than water, with signal transiently enhanced by ~100,000, but eager to return to thermal equilibrium. Thus, HP imaging does not even come naturally to experts in “normal” MRI. Fortunately, tremendous advancements have been made on this front by numerous centers around the world, leading MRI vendors to become increasingly supportive. Thus, making HP gas MRI routine and robust now appears within reach. But perhaps the larger chasm to cross is the one that leads to its embrace by pulmonary clinicians. Today, pulmonologists can go their entire careers without ever ordering an MRI scan.
Adding to the challenge is that all of this chasm-crossing must also be navigated in a setting of highly constrained healthcare spending. Whereas the introduction of MRI itself came in an era of relative enthusiasm for new technology in healthcare, the focus in today’s environment seems to be heavily weighted toward how we can reduce the use of advanced imaging .
So what are the HP gas aficionados to do to advance this promising technology, when the barriers to adoption appear so formidable? The answer to this question is guided by the work of Sarah Svenningsen and coworkers in this issue, who show us the types of study designs needed to move this field from its strong technical foundation to establishing its clinical roots.
Today, many of us working in hyperpolarization are technology enthusiasts. We pursue it because it is novel, elegant, and non-invasive, and provides an endless series of intriguing technical puzzles to solve. To this end, our literature is filled with novel trajectories through k-space, reconstruction algorithms, new spectroscopic signatures, and a variety of correlation, and Bland-Altman plots. Although the technical work in hyperpolarization continues to lay important foundations, it does little to convince physicians to order an HP gas MRI for their patients. To make that happen, we must “sell the benefits, not the features,” as marketers would tell us. Simply put, we must demonstrate how HP gas MRI provides clinical value.
The clinical utility of a test can be defined in many ways and measured in a myriad more. However, we must start by recognizing that diagnostic testing itself cannot generate health benefits for patients . This can only happen if test results are used to improve patient care. Tests must therefore help drive decisions to initiate, modify, stop, or withhold treatment. Although our community has done much to reveal the extraordinary promise of HP gas MRI, it has only begun to scratch the surface when it comes to demonstrating its clinical value.
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