In order to increase the survival and quality of life of cancer patients it is important to make the correct diagnosis such that the optimal treatment can be given. In many cases providing the right treatment will also result in lower costs because of fewer recurrences and a decrease in follow-up treatments. Image-guided therapy and minimally invasive surgery will be increasingly used in the coming years to make adequate diagnoses for various oncological treatments. One of the techniques that can be used here is Optical Coherence Tomography (OCT). OCT is already widely used as a scanning technique in ophthalmology. The next step for OCT is that it will also be applied in vivo (in the body). However, to obtain OCT images in the body a catheter is required.
An prototype OCT-catheter for bladder cancer diagnostics has been developed by Scinvivo in the past years. To be able to use the catheter in the clinic, parts still need to be optimized or developed. These developments will take place in this project. In addition, the OCT catheter has so far only been studied for the application area of diagnosis and treatment of bladder cancer, while the catheter can also be used for other indications within the domains 1) checking resection surfaces of removed tissue for tumor-free and 2) diagnostics of suspicious abnormalities in intestines and lungs. This project therefore also investigates which other indications within these two domains are suitable for the use of the OCT catheter. Next to that, robot control of the catheter will be investigated, to make is possible to easily localize the tumor in the bladder at all times and to create reproducable, physician-independent, results.
The aim of this project is to develop and validate a prototype OCT catheter system with the following properties:
- Provides high image quality with correct image orientation allowing for good distinction between all layers of tissue (lateral and axial resolution of at least 40 µm).
- Can find the exact location of the tumor upon re-entry of the endoscope.
- Does not suffer from movement artifacts caused by the patient’s breathing or heartbeat. (refresh rate above 120 Hz).
- Is robust; in a clinical setting, the catheter must be able to take a beating.
- Provides reproducible results through robotization (results independent of physician and catheter that is renewed per procedure).
- Is patient safe and suitable for use on the operating table (catheter is at least 1.5 m long and meets the requirements of the Medical Device Regulation 2017).
- Is suitable for multiple indications. Other indications will have other requirements that the catheter must meet, such as the diameter of the catheter (possibly less than 2.5 mm in diameter) or the medium in which the catheter can be used (air vs water).
- Has a catheter with a short rigid piece (shorter than 15 mm) and can therefore be used in standard boxes.
- Can be produced on a large scale at a low cost price (lower than € 200 with a production volume of at least 10,000 pieces per year).
Within this project three phases can be distinguished: 1) the definition phase in which the requirements are established for the prototype OCT catheter system, 2) the development phase in which various innovative parts are developed to improve the proof-of-concept catheter, 3) the clinical trial in which the prototype catheter will be tested and validated in patients.
The project is carried out by four partners. The first is Scinvivo (SME), responsible for the development of the prototype OCT catheter and parts of the prototype OCT catheter system. The second is Bruco (SME), responsible for developing the prototype ASIC, an essential part of the catheter. The third is the Radboudumc, which is researching the possible areas of application of the catheter and also carries out the valorisation of the OCT catheter in tissues and subsequently in patients. The fourth partner, University of Twente, is responsible for the development of imaging software and robot control.
The project is funded by Operationeel Programma Oost (OPOost).