Imaging and Data Acquisition in Clinical Trials for Radiation Therapy

Abstract

Cancer treatment evolves through oncology clinical trials. Cancer trials are multimodality and complex. Assuring high quality data are available to answer not only study objectives but also questions not anticipated at study initiation is the role of quality assurance. The National Cancer Institute reorganized its cancer clinical trials program in 2014. The National Clinical Trials Network (NCTN) was formed and within it, established a Diagnostic Imaging and Radiation Therapy Quality Assurance Organization. This organization is IROC, the Imaging and Radiation Oncology Core Group, comprised of six quality assurance centers that provide Imaging and Radiation Therapy Quality Assurance for the NCTN. Sophisticated imaging is used for cancer diagnosis, treatment, and management as well as for the image-driven technologies to plan and execute radiation treatment. Integration of imaging and radiation oncology data acquisition, review, management, and archive strategies are essential for trial compliance and future research. Lessons learned from previous trials are and provide evidence to support diagnostic imaging and radiation therapy data acquisition in NCTN trials.

Performance Observations of Scanner Qualification of NCI-Designated Cancer Centers: Results From the Centers of Quantitative Imaging Excellence (CQIE) Program

“…Indeed, there remain efforts within the NCI and other groups supporting clinical trials with imaging to augment the number of advanced imaging biomarker trials in the United States. To this end, the NCI has reformulated the funding of their National Clinical Trials Network (NCTN) groups, to include the formation of the Imaging and Radiation Oncology Consortium (IROC) for imaging QC efforts in these trials (20,21). …”

The Influence of Imaging in the Modern Practice of Radiation Oncology

“…Today, colleagues at the American College of Radiology and the Imaging and Radiation Oncology Core have created data transfer tools so that fundamental issues of staging, protocol eligibility, therapy response, and radiation therapy planning review can be performed in real time before the patient is treated. These reviews are synergistic to the clinical trial process, strengthen the uniformity of the clinical trial treatment, and ensure that the right patient is on the right trial and is treated in a protocol-compliant manner (1,2). This ensures that imaging is applied to radiation therapy in a protocol-compliant and uniform manner.…”

“…As imaging tools improve and can be successfully registered with radiation planning imaging, targets will be further refined and patient-specific treatment planning optimized with confidence that the target is reproduced correctly every treatment day. Imaging has become symbiotic with all elements of daily practice, and application of emerging imaging tools will be an essential component of modern radiation oncology clinical translational research for the next generation of clinical trial investigators (1).…”

Acquisition and Management of Data for Translational Science in Oncology

“…In pediatrics, the images were not siloed as segregate entities between radiology and radiation therapy but applied symbiotically to all investigators for target definition and assessment of response in a single data review system. This enhanced the synergism between radiologists and radiation oncologists in the care of children [1]. In 2007, a recommendation was made by a group designed to review and assess the cooperative group mechanism and functions.…”