Identifying the right model for a preclinical study can be a significant challenge. The choice often comes down to whether the model shares specific anatomical characteristics with the humans who will eventually be the end users of a particular medical device. Another consideration is the size of the model and how it accommodates a specific medical device.
Once a medical device manufacturer has determined which model is right for their preclinical research, they must also consider device-specific anatomical requirements. Models come in different shapes and sizes, which means the medical product, designed for human anatomy, may not be well-suited for the model. In this case, it may be necessary to customize the size and fabricate a device prior to preclinical trials.
Computerized Tomography (CT) imaging can save time and headaches on many preclinical research projects. With NAMSA’s CT imaging capabilities, image acquisitions of models can help one determine anatomical suitability, as well as device sizing and dimensions.
1) Which Models are Best-Suited for CT Acquisitions?
One issue with CT acquisitions from preclinical models is their weight and size. Not all preclinical models are physically suited for the procedure. For example, calves can exceed the weight limits very quickly.
The other requirement is the resting heart rate of a preclinical model; to obtain a clear image of the cardiac system, the pulse must fall within a certain range. For example, this is why humans are often given beta blockers for CT procedures—but unlike humans, there are few safe methods to lower the heart rate of preclinical models.
Rabbits have high pulse rates and are not well suited for CT scanning procedures, however, larger species have the physical and cardiac traits to allow for a successful acquisition.
2) Who Conducts CT Acquisitions?
At NAMSA, all CT acquisitions are completed in-house by skilled Interventionalists/Surgeons and trained Surgical Technicians.
3) What are NAMSA’s CT Capabilities?
NAMSA recently updated its CT system to the Siemens Somatom Definition Flash. This not only enhances our current capabilities, but also offers the potential to expand services based on client demand.
Below are just a few examples of the benefits of these capabilities:
a) More detectors, better imaging: Having a system with more detectors than a previous model means NAMSA can acquire more data in less time. This is particularly relevant in cardiac scans, where NAMSA can acquire imaging without lowering a preclinical model’s heart rate.
b) Dual energy/spectral acquisitions: An area for potential future expansion is the ability to analyze solids in the anatomy, such as vascular calcification or renal calculi.
c) Interventional models: NAMSA’s CT hardware allows for interventional procedures in CT, including in-room screening, tableside controls and a foot pedal for live imaging. Interventional software can be added on in the future to expand capabilities.
4) How to Prepare for a Successful CT Acquisition
Here are some key items to help ensure medical device Sponsors gain the best possible results when including CT imaging as a part of preclinical research.
- Schedule a Review
First and foremost, schedule a review of your image(s) DVD with the CT acquisition quickly—ideally, within the first three months. Since the files are large, NAMSA can only store a limited number of past jobs on its system. Depending on workload, images are removed from the system within six to eight months.
- Quality Check
As images are reviewed, Sponsors will want to ensure they received complete image acquisition of their target anatomy.
- Seek an Expert for Analysis
If a Sponsor requires an analysis of the images and data from the CT acquisition, you may consult with a NAMSA Radiologist or our Imaging Core Lab.
- Update your System Software
To review images on a DVD, one must have a CT compatible viewer. Many free and paid DICOM viewers are available, and our technical experts can assist with recommending one that’s right for your organization.
How can NAMSA Help?
When it comes to successful research studies, experience matters. NAMSA has amassed the largest breadth and depth of therapeutic expertise and knowledge, more than any other preclinical development partner in industry. NAMSA’s preclinical research and histology services provide support for all model types, treatments and implant requirements, including the areas of: Cardiovascular, Dental, Dermal, Electrophysiology, Gastrointestinal, Neuromodulation, Orthopedics, Pulmonary, Urogenital, Wound Healing and several others.
To learn more about NAMSA’s imaging capabilities, including CT imaging, ultrasound, fluoroscopy and more, we invite you to visit: https://namsa.com/services/preclinical-research/.
Be sure to schedule your 30-minute complimentary consultation to learn about our full suite of preclinical research solutions and how we can successfully lead you through all phases of your preclinical research project. Learn more about our experts, or schedule a consultation, here: https://namsa.com/namsa-expertise/subject-matter-experts/.
Monica Tantalean, BS, AAS, CVT currently serves as NAMSA’s Global Marketing Specialist—Lab Services and joined the organization with the acquisition of American Preclinical Services (APS) in 2021. She has been with APS since 2017. Monica has 7 years' experience within the medical device and veterinary healthcare industries and has worked in a variety of roles from Surgical Technician to Business Development. In her role at NAMSA, she is responsible for assisting with the development and execution of marketing communications that contribute to organizational growth and sales.