Benefiting from appropriate imaging modality

How the integration of appropriate imaging modality increases the efficiency of clinical trials. By Michael Morales and Bruce Hillman

The capabilities of imaging today possess far more extensive applications than existed 100 years ago. With conventional procedures being replaced or enhanced with more advanced novel imaging or nuclear modalities, researchers are gaining a wealth of resources for various functions. Thus, imaging plays a far more active role in the development process. Moreover, the integration of the appropriate imaging technique in a development program reduces necessary time and costs, thereby increasing its efficiency.

In selecting the most appropriate modality, several considerations must be made. Each development program possesses distinct attributes and goals that must be addressed before imaging can be integrated. How will the imaging be utilized? Will the information serve as a biomarker, endpoint or marketing tool? In each of these situations, imaging operates in a different capacity. As a biomarker, imaging provides a more comprehensive analysis of therapeutic effects and pathways of action; in early phases, imaging can be incorporated to elucidate mechanisms, reveal drug activity and assess the value of a new medical device. As an endpoint, imaging shortens the time to reach conclusions. During certain situations, data may be collected that will not contribute to the regulatory application; this imaging is often useful in marketing functions after approval has been received. Thus, imaging plays a role in every step of the development process.            

If properly employed, imaging reduces time and cost expenditures primarily by lowering variability in decision making. With earlier results in safety and efficacy, researchers can make go/no-go decisions sooner without consuming unnecessary energies while waiting. One application of this exists when changes in glucose uptake in cells over time is critical to the recognition of drug activity; including a conventional PET scan using F18-FDG eliminates the wait as FDG more quickly mimics the actions of glucose. Likewise, DCE-MRI allows earlier estimates of drug efficacy by examining the vascular changes in a tumor, which begin more quickly than actual tumor shrinkage.

However, imaging solutions would lack relevance without cohesive data management, which actively demands standardization in data acquisition, management, quality control, archival and analysis. The first step in standardized data acquisition is validation, which examines and qualifies the utilized technology as a whole, including the computers and users. Because image acquisition involves an inherent risk for human error, users must be trained in accordance with SOPs and GCPs while the technology is being tested to create an environment of control. Image management must establish means of source documentation in accordance with HIPPA regulations and must ensure the integrity of the image collected during interpretation and quantitative analysis. Because source data must be attributable, legible, contemporaneous, original and accurate, some method of archival must also be established.

ACR Image Metrix utilizes a proprietary system, TRIAD OA, for the anonymization, re-identification, analysis and archival of image data. TRIAD represents the data management changes that imaging has effected in the development program environment because it supports seamless, rapid management of data through the use of the web. Where sharing images once involved multiple steps, now data can be uploaded onto a secure site to promote instantaneous action. Without delays in image transfer, the image can be QC'd by the imaging technologist for readers to perform interpretation and quantitative analysis more quickly, without information getting lost between steps.

Henceforth, imaging will continue to play a larger role in development programs, from start-up to post-marketing activities. As this technology continues to be refined, its role in clinical development will only increase. Already, its benefits boast streamlining the decision making process and necessitating stronger operational data management processes. Clearly, imaging's contributions to success justify its inclusion in your study today.

Michael Morales holds the position of General Manager with ACR Image Metrix. As such, Morales has responsibility for strategic, tactical and financial operations. His accrual of over 30 years of experience in organizing and coordinating large-scale clinical research to accelerate drug development programs involving imaging is critical to the success of his position.

Bruce Hillman, M.D., is the Chief Scientific Officer for ACR Image Metrix. He has been selected for Who's Who in Medicine and Healthcare and Who's Who in the World. Prior to his experience with ACR Image Metrix, Dr. Hillman was the chair and principal investigator of the American College of Radiology Imaging Network (ACRIN).