The Academy of Radiology Research (ARR) strongly supports the President’s effort to advance cancer research and cures through a proposed investment of $1.0 billion that will be used to “accelerate progress in preventing, diagnosing, and treating cancer,” by supporting research and infrastructure. Scientists from the imaging research community should be called upon to use their extensive expertise and experience to help inform and facilitate the Administration’s efforts. This Policy Statement succinctly addresses the following major components of the contributions imaging researchers can make to this endeavor:
- The role of imaging in cancer research and treatment.
- Computational science and big data.
- Improving research and outcomes by supporting educational pathways for young researchers.
- The role of the Interagency Working Group on Medical Imaging (IWGMI) to advance cancer research.
- Imaging research as a support for FDA efforts to create novel products.
The Role of Imaging in Cancer Research and Treatment
Medical Imaging plays a central, critical, and irreplaceable role in early cancer detection, diagnosis, treatment planning and monitoring. The contribution of medical imaging to cancer diagnosis and treatment can be divided into at least two major categories— i.) Diagnostic imaging and treatment monitoring and ii.) Image-guided interventions.
Molecular Imaging and Treatment Monitoring:
Imaging beyond structure and morphology are major initiatives which see in-vivo evaluation of cancer and pre-cancerous conditions. Current work in functional, molecular and quantitative imaging already play important roles in early detection of cancer, precise diagnosis and characterization of tumors (particularly when combined with quantitative information from feature analytics, radiomics and genomics) and monitoring the response to therapy, and the creation of databases for deep learning. Imaging is a valuable tool to identify and characterize ‘target’ lesions that have the potential to be malignant.
Being able to identify the appropriate target lesions to guide biopsy and obtain the relevant genomics profiling will guide treatment choice, impact patient management, improve health outcomes and save lives. Advanced functional and metabolic imaging, such as molecular imaging, highlights active portions of a cancer, enabling precise medical interventions with improved patient outcomes. New image processing methods combined with machine learning can predict important genomic properties of tumors from routine MRI images. This technique, sometimes referred to as ‘virtual biopsy’ can allow comprehensive sampling of tumors both in space and in time, avoiding the need for repeated biopsy.
Imaging also plays a critical role in the advances of novel therapeutics for cancer, as it objectively defines clinical trial endpoints and thus provides a basis for the regulatory approvals of new anti-cancer agents for their clinical application. The role of imaging is increasing in the current era of precision cancer therapy, where a growing number of novel agents are being approved and prescribed in the clinical setting.
Multiple imaging modalities have matured as a means to guide and monitor the performance of minimally-invasive procedures. In current practice, X-ray, fluoroscopy, CT, MRI, PET and ultrasound technologies are used every day as guidance tools. Newer handheld probes are in development, such as optical and mass spectrometry probes. When used in real-time, these may allow for improved targeting, reduction of positive margins, more complete excision or, in the case of radiation delivery, this approach can allow for escalation without increased toxicity.
Another major research focus is in-vivo tissue sampling and ultimately non-invasive biomarkers of disease and response. Image-guided device development and testing is underway to facilitate both tissue retrieval for in-vivo/in vitro characterization, guide the performance of surgical interventions, or focal tumor ablative procedures or targeted drug delivery. The expanding field of interventional oncology encompasses a variety of image-guided approaches to deliver potent therapies directly to tumors with minimal toxicity to the surrounding tissue.
Such techniques have substantially diminished the need for open surgery and its associated morbidity and mortality. Developing low cost, precise imaging technologies can have a great impact on reducing patient mortality.
Additionally, precision image-guided surgery, where a surgeon is guided by real-time images of the target tumor, often at its cellular level, enables complete removal of the tumor with minimal damage to the surrounding healthy tissues while assuring no residual tumor is left behind. Real time mass spectrometry is under investigation during glioblastoma resection, with a goal to optimize the tumor resection.
Non-invasive image-guided interventions have been pioneered, such as MR-guided Focused Ultrasound (MRgFUS). This technique can be used for focal tissue thermo-coagulation, ablation, can guide and monitor localized drug delivery and with its unique ability to open the blood-brain barrier can allow for passage of large molecules into the brain. This innovation will lead to major changes in neuro-oncology and all fields of oncology.
Improving Cancer Research and Outcomes Through the Use of Medical Imaging
New and novel imaging techniques, devices and agents are all in development, and although progress is slow, adoption is even slower and ultimate acceptance by payers and the community is fraught with difficulty. Many useful imaging agents (e.g. several PET agents) have not made their way into the clinic in the US, yet their use is commonplace in many other countries. Closing this gap is possible through streamlined processes that bring laboratory research into the clinical practice. These goals can be actualized through better coordination among NIH research, the FDA approval process, and updated CMS review for reimbursement.
Computational science research and big data:
Medical images provide a rich source of data that describe anatomic and functional phenotypes of patients and their disease processes. This information is complementary to genetic information and will have an important role in characterizing cancer progression, particularly the development of heterogeneity on a local and global scale. There has been tremendous progress in the use of computational methods to characterize imaging phenotypes in a quantifiable and reproducible way through the efforts of the QIN network and others. These efforts should be encouraged for imaging phenotype data to contribute (alongside genetic and other data) to our understanding of cancer biology and progression in individual patients.
In support of these efforts, the development and support of cancer image repositories that provide researchers access to high-quality imagery from multiple modalities and associated genetic, clinical and outcome data would be critical. Expansion of the efforts of the The Cancer Imaging Archive, coordinated with imaging data collected as part of the National Clinical Trials Network would provide a unique resource to accelerate progress.
Improving Research and Outcomes by Supporting Educational Pathways for Young Researchers
Increasing opportunities for talented young people to enter the research and medical workforce is pivotal to efforts to improve research and medical outcomes. Students entering the physician-scientist workforce face a number of key challenges including enormous student debt and limited employment opportunities. Increasing support for students and for innovative education and workforce development pathways can accelerate the President’s efforts to advance research and improve outcomes. Support for early and mid-career physician scientists on their pathway to independence is also essential for the continued growth of the field. Education of the next generation of translational imaging clinician scientists is pivotal to creating the workforce to implement these admirable goals.
The Role of the Interagency Working Group on Medical Imaging (IWGMI) to Advance Cancer Research
The Administration should fully utilize the deep expertise of the IWGMI as a tool to advance the Moonshot’s efforts for precise and improved cancer research and outcomes. By targeting the work of the IWGMI to include an emphasis on cancer, in conjunction with efforts to enhance the role of diagnostic imaging and image-guided therapy in other diseases, the Administration can utilize the existing Working Group as a critical research resource and maximize coordination among government agencies.
Imaging Research as a Support for FDA Efforts to Create Novel Products
The Food and Drug Administration’s proposed Virtual Center of Excellence aimed at combining drugs, biologics, and devices to develop new products should utilize imaging resources to the largest extent possible to support their initiatives. Molecular imaging has the potential not only to characterize the tumor and to guide proper choice of therapy, but also track noninvasively the bio-distribution of drugs and biologics, assess target hits and predict response to therapy soon after initiation of therapy, enhancing the understanding of products safety and effectiveness. Additionally, the Center could consider developing devices for image-guided interventional procedures. Imaging biomarkers and endpoints and biomarkers are critical for the evaluation of the efficacy and effectiveness of cancer treatment, and enhancing imaging resources will provide support for cancer researchers and clinicians across the country.
The Academy of Radiology Research strongly supports the President’s effort to advance cancer research and cures through a proposed investment of $1.0 billion that will be used to “accelerate progress in preventing, diagnosing, and treating cancer,” through the focused and aggressive support of research and infrastructure development. The imaging research community has a significant role to play and their extensive expertise and experience will help inform and facilitate this important initiative.
This Policy Statement succinctly conveys the role this community can play to make this endeavor the success it must be to justify the investment of the American people’s tax dollars. From the role of imaging in cancer research and treatment; the utilization of computational science and big data; improving research and outcomes by supporting educational pathways for young researchers; to the role of the Interagency Working Group on Medical Imaging (IWGMI) to advance cancer research; and, imaging research as a support for FDA efforts to create novel products, the work of the imaging research community will be a key component to the ultimate success of this critical scientific initiative.