Medical imaging has become a crucial tool for diagnosis and clinical research. Imaging services in an academic medical institution like the University of Chicago Medicine are used by dozens of departments for everyday patient care and clinical trials, making them subject to a bewildering array of policies and procedures to protect patient privacy and preserve the integrity of data. Navigating this labyrinth of issues can be a logistical headache for researchers, so to solve this problem a group of imaging scientists and radiologists at the University of Chicago Medicine formed an office with a name that promises to save the day for investigators who need medical imaging for their clinical trials.
The Human Imaging Research Office, or HIRO, may very well seem heroic to clinical trial investigators who need CT scans, MRI scans and X-ray images to go along with the rest of their research data. The HIRO was established through the Imaging Research Institute (IRI) of the Biological Sciences Division to coordinate the acquisition, collection, analysis and maintenance of images used for clinical research involving human subjects. Since it was created in early 2009, the HIRO has assisted with 191 research protocols and has delivered more than 44,000,000 images and associated reports to researchers.
Samuel Armato III, PhD, associate professor of radiology and faculty director of the HIRO, said that imaging has become a bigger component of clinical trials in recent years. “Usually imaging isn’t the focus of the study, but it’s quite often used as a measure of whether or not the drug is working,” he said. “The drug companies in particular prefer to have imaging standardized across all of the sites that are participating in the trial.”
These clinical trials have very specific requirements for images that may differ from the conventional way an image might be created in everyday clinical practice. Laying the groundwork can be a challenge for someone who isn’t familiar with the intricacies of radiology.
Armato said this is where the HIRO comes into play. “Clinical trial groups often didn’t fully appreciate the complexities involved with imaging, and they would call around to try and find someone to answer their questions. It was just one phone call after another that led to a lot of frustration,” he said. “We came along to help bridge that gap between clinical research and the imaging component of that research.”
Nick Gruszauskas, PhD, technical director of the HIRO said, “We know that ordering a CT scan of the chest isn’t like ordering a lab test that’s performed the same way every time. There are several dozen perfectly reasonable and useful ways that we could perform that CT of the chest. If the investigators requesting the scan don’t specify what they want, then the radiologist and technologist are going to use their best judgment on how to do it. But that may not be what the drug company wants for the clinical trial.”
Besides making extra work for radiology staff, repeating a scan for a clinical trial because it was done incorrectly the first time poses risks for the subject. It could expose them to radiation a second time unnecessarily. In the worst case, the window of opportunity to capture an image at a specific time could pass and the subject could be removed from the trial. This is a double whammy: The researcher loses a valuable subject, and the subject misses out on the potential benefits of the trial.
Gruszauskas said the confusion over technical requirements for research imaging also puts a burden on radiology staff. “A patient might show up in their area with an order for a CT, and then stapled to that order would be a 2-3 page pamphlet from the clinical trial that describes how this scan is supposed to be done,” he said. “Having a patient just show up with this packet of information that the tech is supposed to implement on the spot is simply inefficient.”
The solution, he said, is to collaborate beforehand to iron out these technical details. Someone from the HIRO now performs a review on any research protocol that goes through the Clinical Trials Research Committee at the medical center. This lets them identify any potential snags in the imaging requirements, and line up the appropriate resources to make sure the investigators get exactly what they need for their trial.
Researchers are not required to submit their trials to the HIRO, but Gruszauskas said that doing so ensures that things go smoothly. “We have excellent relationships with various people in radiology, and we’re continuing to build up more infrastructure to have the process go as smoothly as possible,” he said.
The HIRO provides a site visit packet with details about the Department of Radiology infrastructure to pharmaceutical company representatives who are evaluating the medical center for a trial. They also have a website where they explain the technical requirements for every research protocol they have reviewed. Radiology staff can then refer to this information when it’s time to perform the scan.
The HIRO website also allows researchers to request copies of images to be used for research. Such images often have a patient’s personal health information embedded in the metadata or on the image itself, and the HIRO has staff who specialize in editing images to adhere to privacy standards.
Armato said that the HIRO is a work in progress, and probably always will be. “It’s one of these ongoing projects that must adapt to the changing needs of researchers,” he said. “Just when we think everything is under control, some new twist on a theme comes up and we need to figure out how to enhance the process again.”
But both he and Gruszauskas said that the ultimate success of the HIRO lies in overcoming long-established habits that researchers developed from years of trying to figure out their imaging needs on their own. “Once you’ve been doing it in an ad hoc manner for years, you might realize it’s not the best way to go about it, but you don’t have time to figure out another way,” Gruszauskas said. “Getting people away from that is difficult.”
In the complex and technical world of radiology, in which juggling standard patient care with sophisticated clinical research is commonplace, it helps to have a HIRO take charge and save the day.
Armato, S., Gruszauskas, N., MacMahon, H., Torno, M., Li, F., Engelmann, R., Starkey, A., Pudela, C., Marino, J., Santiago, F., Chang, P., & Giger, M. (2012). Research Imaging in an Academic Medical Center Academic Radiology, 19 (6), 762-771 DOI: 10.1016/j.acra.2012.02.002