May 1, 2018 – The DCRI’s Precision Imaging Program is building on its record of success by adding new technologies and capabilities.
DCRI Imaging launched its Core Lab in 2007 and has worked on many different trials both big and small. What makes the team so successful?
From the time we launched, we set about differentiating ourselves by offering excellence along with continued innovation. We offer the very latest imaging capabilities across therapeutic areas and are rapidly developing even more. Our modalities and applications currently include echocardiography, angiography, ECGs, MRIs, computed tomography, x-rays, and ultrasound—all providing the best quality imaging data for the most accurate results and greatest value to the parent research studies.
Moving forward, we’re building on our record of success. We are looking at harnessing new technologies, applications, and software within our program. For example, while we have an active 3D program, we are planning for the future by considering adding telemedicine, device imaging, remote imaging, image adjudication, and data capture to our offerings, while keeping all that is good and proven about our current program.
Your team does a lot of work for both industry and government sponsors. What should researchers know about the many services you offer?
As a problem-solving group, we’ve enjoyed the support of industry sponsors and extensive repeat business for more than a decade. We’d like to encourage all DCRI investigators to add us to the conversation whenever considering a new study for which imaging can add efficacy or safety information.
Our goal is to harness the capabilities of each of our modalities to provide a deeper understanding of study results, including mechanisms of action and detailed outcomes. The GUIDE-IT heart failure management strategy trial is a perfect example. In this study, clinical data alone failed to prove the primary hypothesis. Through imaging, we demonstrated a positive impact that had not been visible otherwise; specifically, the echocardiographic findings revealed critical differences between subjects in their response to treatment which was dramatically associated with the effectiveness of medical therapy.
Through our close participation with the ASE (American Society of Echocardiography), ACC (American College of Cardiology), and the U.S. FDA, we led the development of these Societies’ and agency’s best practice standards for echocardiograms (echoes) in clinical research and imaging informatics.
When we work on clinical research trials, we are contributing investigators sharing our expertise and services, active partners with sponsors and trial leadership, and a vital step toward the most comprehensive and accurate results.
What are some of the trials DCRI Imaging has worked on?
One of our earliest studies was the landmark PARTNER (Placement of Aortic Transcatheter Valves) trial, the first ever randomized trial of percutaneous aortic valve replacement for severe aortic stenosis. The study included nearly 3,300 patients and more than 17,000 echoes and has led to more than 30 publications (and counting!) for DCRI investigators.
More recently, we became the core echo lab for another innovative intervention for cardiac valve disease: percutaneous mitral valve replacements. The MITRAL trial results were presented as late breaking clinical trials at TCT and at the AHA Scientific Sessions in fall 2017 and have significantly extended the use of devices for structural heart diseases.
Today, we’re the Imaging Coordinating Center for the BASELINE study funded by Verily Life Sciences. This study aims to fundamentally redefine the molecular and other definitions of health and disease. The imaging modalities we are contributing include rest echo, stress echo, and rest ECG, all familiar to us, as well as introducing ophthalmologic and radiologic imaging. Adding these modalities has meant forging new, highly collaborative relationships with the Duke Eye Center and Duke Radiology. In total, we’re coordinating nine imaging modalities on this study, which is very exciting.
When is the best time for researchers to bring the Imaging team into a study?
As soon as possible, even during the early phase of concept discussions. We can consult with teams on the best imaging strategy even before writing their protocol—asking ‘what information can imaging provide to assist in addressing the scientific question?’—and then figuring out a plan to capture this, including the right modality at the right time and analyzed in the right way. Of course, we’re delighted to work on any study for which we can add value—we are adept at rescue studies, too.