Customizing Clinical Trial Imaging to Support a Claim: A Case Study

Amit Vasanji, Ph.D. | |

We sat down with Amit Vasanji, PhD, ERT’s Chief Technical Officer of Imaging, to learn how the combination of technology, scientific expertise, and creative problem-solving is critical to meeting clinical trial imaging needs and to understand how Medtronic applied all three to achieve their trial objectives.

How do clinical researchers meet regulatory requests for clinical trial imaging?

Most pharmaceutical companies and CROs find it difficult to meet regulators’ increasing requests for quantitative image analysis of clinical trial data. With limited in-house imaging capabilities, including the use of manual, qualitative assessments, many turn to third-party imaging vendors. But few of these firms have the combination of scientific knowledge and advanced technological and operational expertise needed to expedite these requests and deliver scientifically validated results.

Keep going to read an overview of how Medtronic used imaging to demonstrate product superiority or download the case study here.

What was Medtronic’s imaging challenge?

Covidien ─ a Medtronic subsidiary that manufactures about half of the surgical staples on the market ─ needed sound scientific evidence proving the hypothesis that their graduated-height staples are superior to competitors’ single-height staples with respect to tissue perfusion and long-term tissue viability. To accomplish this, Medtronic turned to ERT, not only for imaging analysis but for an entirely new research approach that would help them make their case in a peer-reviewed paper.

How was the study designed?

The main purpose of the study was to find out whether Medtronic’s graduated-height staples allowed more blood perfusion ─ promoting wound healing ─ than did single-height staples. ERT helped design the protocols, including the selection of the contrast agent and its formulation, and employed a quantitative method sensitive enough to measure micro-perfusion of stapled tissue.

Subsequently, ERT scientists designed and implemented an appropriate image-acquisition protocol and customized segmentation algorithms to extract specific quantitative metrics that measured the ability of staples to maintain vascular perfusion. Since the algorithm was fully automated, multiple experimental runs were analyzed in batch after each imaging session.

What was the result?

The novel experimental design provided quantitative validation of Medtronic’s hypothesis ─ that their graduated-height staples enable greater perfusion than competitors’ single-height staples. As a result, Medtronic produced a report, published in Medical Devices: Evidence and Research, that showed the clear superiority of its staples in terms of blood perfusion along the staple line.

Clinical trial sponsors rely on ERT to design and conduct imaging studies from small preclinical trials all the way to large, multisite, late-stage clinical trials. Because ERT uses its own pre-validated core software, it can quickly tailor its base platform to meet the requirements of a particular trial and reduce study start-up times.

Click here to learn how ERT’s scientific expertise and purpose-built, advanced imaging technology can help you meet your clinical trial imaging needs.