Lise Lindquist is a Clinical Data Manager at QT Ultrasound, a company using Medrio to collect critical data to support their clinical research and product development for their FDA-cleared true 3D breast imaging system. The company aims to change the paradigm of breast cancer detection. Last year, they received Breakthrough Device Designation from the FDA, who recognized that the modality they’re developing satisfies an unmet medical need for younger women at high risk for breast cancer. We sat down with Lise to talk about their innovative research.
Talking imaging innovations with Lise Lindquist
Medrio: Thanks for taking the time to chat today, Lise. Can you tell us a bit about your role, the kind of work QT Ultrasound does, and your experience with Medrio?
Lise Lindquist:. I’m a Clinical Data Manager at QT Ultrasound. I’ve had varied experience over my clinical career– I’ve worked in pharma and medical device, at sponsor companies and at CROs – but what I’m working on now at QT is very different. We’re doing research on a new imaging modality for breast cancer detection along the lines of mammography, MRI, or CT. Our mission is to provide a safe and comfortable imaging modality that can truly provide the breast health information women need and deserve.
In some ways, our research isn’t so different from what other companies are doing. Like other companies, we’re conducting traditional clinical trials, enrolling patients, and collecting data. But the difference is that we’re also doing reader studies in which we collect images, and then periodically fly in radiologists from all over the country and have them read our images and give us data about them. We’re using Medrio to collect the data for these studies as well, and in this regard, our use of Medrio is quite different from how many other companies use EDC.
M: What’s unique about the breast imaging modality that QT Ultrasound is working on currently?
LL: Breast cancer diagnostics is a multi-phase process. It starts with a mammogram, with the potential biopsy occurring further down the line, after additional adjunctive imaging. The issue is that existing imaging technology isn’t always able to distinguish between benign and malignant masses in the breast, and so a lot of these biopsies are performed on what end up being benign lesions. Women are going through this painful procedure that involves a needle and a fluid draw, as well as the emotional toll of waiting and worrying that they may be seriously ill, and all of that could have been avoided if the imaging process had been better able to see that the lesion was benign. So, what we’re trying to do is prevent these unnecessary biopsies, which can go a long way toward improving the quality of life and delivering a better experience to women. Our imaging modality is free of a lot of the unpleasant aspects of other imaging modalities such as compression, radiation, and injection of contrast.
QT Ultrasound also has the crucial ability to see through dense breasts. About 50% of mammography-age women have dense breasts, and this poses a challenge for traditional mammography. Mammography can’t see well through dense breasts. Many states have laws requiring mammography centers to inform women if they have dense breast tissue. Their healthcare providers often recommend they go for further testing. Our QTscan is FDA-cleared as an adjunct or follow-up to those initial screening mammograms and can deliver the insights women and their providers are looking for.
M: CRO outsourcing is a big topic in clinical research today. What informs QT Ultrasound’s decisions about whether to outsource your clinical operations or conduct your trials in house?
LL: We do all our clinical studies in house. We work in a pretty specific niche, and it can be hard to find a CRO with the specific expertise to take on this type of trial. At the end of the day, while we recognize the benefits of outsourcing in many cases, no one knows and loves your data as much as you do. The good news is that Medrio makes it easy and affordable to do our studies in house. With other EDC vendors, you have to know how to write a custom function just to create a subject ID in the correct format, or to receive email notifications. Medrio’s intuitive design makes this easy for anyone to do with very minimal training. So Medrio is good for both companies that like to work with CROs, and for companies, like ours, that prefer to do their trials internally.
M: Thanks so much for talking with me today, Lise.
LL: Of course – thanks for a good chat!