Frequently Asked Questions

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Why is imaging so important in your drug or device study?

Imaging offers both pharmaceutical and medical device investigations more efficient endpoints and biomarkers to drive internal decision making. The traditional use of imaging has been as a surrogate endpoint in Phase III trials, which allows us to shorten the time necessary to reach a conclusion as to the effectiveness of a drug. The new techniques are more mechanistically oriented. For this reason, imaging is being used in earlier research phases as a biomarker to help elucidate mechanisms, demonstrate drug activity and to provide the clinical data to determine whether a device might prove worthwhile. This approach saves time and money because, if used properly, imaging can lower the variability in influencing go/no-go verdicts and other decisions.

What important trends are you seeing in imaging trials?

Imaging is increasingly being used very diffusely in all spheres, and the technologies vary by application. For example, ACR Image Metrix™ sees an enormous amount of use in oncology. Imaging can be used to determine whether there is activity in an anti-angiogenic agent, whether there is an effect in some of the genetic mutation-related cancers, whether there is healing in the joint space or cartilage development and in the cardiovascular area to help us determine whether there are important therapeutic effects and the pathway of action.

Clinical radiology, until recently, has essentially comprised qualitative imaging techniques. However, an increasing number of approaches to quantitative analysis have been pursued, which create objective quantitative readouts that range from morphological to functional measurements. Quantitative imaging readouts allow for volumetric measurements, which lead to an increased accuracy in gauging the effectiveness of a new drug.

One innovative imaging test that comes up a lot is a technique called dynamic contrast-enhanced MRI (DCE-MRI). Although difficult to implement in any sizable scale, DCE-MRI is mainly applicable to agents that are working on microvascular abnormalities. Another test that may be very valuable in some trials is a conventional PET scan using F18-FDG. This may complement trials where the changes in glucose uptake in cells over time are critical to your recognition of drug activity.

What sets ACR Image Metrix apart from other imaging core laboratory providers?

The value-added benefits that establish ACR Image Metrix as the next generation imaging CRO are founded in scientific acumen and personal attention. We approach your project with a scientific perspective from the highest level, which comes from years of conducting trials in the ACR Clinical Research Center. If you express a concern, you won’t get some functionary; you will gain access to the core leadership of ACR Image Metrix. Due to our strong operational structure and focus on full GCP compliance, our clinical research center pays particular attention to the regulatory aspects regarding clinical research to ensure data we generate for you will hold up to scrutiny when it is submitted to regulatory agencies.