Background

Cardiac MRI and CT are increasingly used in the diagnosis and treatment of patients with congenital heart disease. Accurately capturing dynamic, fluid-based processes within the body can be a significant challenge in medical imaging. However, it can be difficult to distinguish between blood vessels that are flowing at different rates or to accurately capture the behavior of contrast agents as they move through the bloodstream. To address this challenge, researchers have developed flow phantoms for medical imaging studies.

Flow phantom

Flow phantoms were invented to provide a standardized, controlled environment for simulating fluid flow. This enables researchers to more accurately test and optimize imaging techniques for fluid-based processes. In fact, using flow phantoms for a proof of concept before moving on to human experiments is a safer approach in flow imaging research. Flow phantoms have become increasingly sophisticated over time, incorporating advanced materials and technologies to more accurately simulate the properties of blood and other fluids. They are now widely used in medical imaging research and development, as well as in clinical practice, to help improve the accuracy and effectiveness of imaging techniques for a wide range of medical conditions.

Flow phantom in our project overview

In our project, we aim to establish an in vitro flow system that can be implemented in CT scanning. We will use different materials and CAD designs to fabricate our flow phantom in order to provide optimal X-ray-based flow field measurements. The first objective of this project is to calculate Reynolds’ number based on our flow phantoms design (geometry, calibers, and material). Next, we will compare our in vitro flow system measurements using a magnetic flowmeter with an in-silico simulation from one of our mentors, Rick Guo’s algorithm. The ultimate goal is to leverage Rick Guo’s convolutional neural network (CNN) framework to incorporate relevant flow constraints in our flow system, so that we can compare the flow profile between experiments in-silico and in vitro. Researchers will be able to use the values from the flow meter and control the flow conditions as the ground truth in order to justify the accuracy of imaging measurements.

Relevant Standards

Because flow phantoms are considered medical devices and are classified as Class II medical devices by the FDA. They do require premarket clearance or approval from the FDA. To demonstrate the safety and effectiveness, and to meet applicable regulatory standards, there are several relevant standards and guidelines that we referred to during the design of flow phantoms. These include:

ISO 13485: This is the international standard that is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.
ASTM F1841: This is a standard that specifies test methods for the evaluation of performance characteristics of flow phantoms.
FDA guidance documents: The FDA has issued guidance documents that provide recommendations for the design, testing, and use of medical devices, including flow phantoms.

Leader: Tangran (Tony) Dong

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