Abstract
In order to improve the accuracy of SLNB in FOM cancer patients, and explore the magnetic approach as alternative to the conventional technique using radioisotopes. The aim of this thesis is twofold: At first, gain insight in the magnetic SLNB procedure in oral cancer patients, using a clinically available magnetic probe (Sentimag®). Second, establish a safe DiffMag handheld probe prototype for clinical investigation.
The first part of this thesis discusses the clinical application of magnetic SLNB in OSCC patients. In Chapter 2 an evaluation on novel SLNB imaging techniques for early-stage OSCC is given, one of them is MR lymphography. An overview is given on their diagnostic accuracy, relative merits, disadvantages and potential applications. In Chapter 3 we present a clinical feasibility study, using Sentimag®, covering a complete magnetic SLNB procedure in ten OSCC patients: injection, preoperative imaging to surgical removal of the lymph nodes, and histopathological examination. Which is followed by an additional analysis to the lymphatic drainage of the magnetic tracer for eight OSCC patients of the feasibility study. Based on these initial results, the iron content in SLNs is determined and a proposal is made for the iron grading of SLNs on MRI and histopathological examination in Chapter 4. The second part focuses on the technical aspects of DiffMag handheld probe development and how to get it safe for clinical application. For this purpose in Chapter 5 specifications (detection depth, lateral detection distance and resolving power) are determined for DiffMag handheld probe in a comparison study with Sentimag® and a gamma probe. Chapter 6 gives an overview of the process of qualifying a medical device (in this case DiffMag handheld probe) for clinical use, encountering the new MDR, applicable standards, analyzed risks and adaptations made to the system. Furthermore lessons learned during this process and advice to others to support their development process is given. Chapter 7 provides a general conclusion and future perspectives regarding the magnetic SLNB procedure in OSCC patients and the use of DiffMag handheld probe
The first part of this thesis discusses the clinical application of magnetic SLNB in OSCC patients. In Chapter 2 an evaluation on novel SLNB imaging techniques for early-stage OSCC is given, one of them is MR lymphography. An overview is given on their diagnostic accuracy, relative merits, disadvantages and potential applications. In Chapter 3 we present a clinical feasibility study, using Sentimag®, covering a complete magnetic SLNB procedure in ten OSCC patients: injection, preoperative imaging to surgical removal of the lymph nodes, and histopathological examination. Which is followed by an additional analysis to the lymphatic drainage of the magnetic tracer for eight OSCC patients of the feasibility study. Based on these initial results, the iron content in SLNs is determined and a proposal is made for the iron grading of SLNs on MRI and histopathological examination in Chapter 4. The second part focuses on the technical aspects of DiffMag handheld probe development and how to get it safe for clinical application. For this purpose in Chapter 5 specifications (detection depth, lateral detection distance and resolving power) are determined for DiffMag handheld probe in a comparison study with Sentimag® and a gamma probe. Chapter 6 gives an overview of the process of qualifying a medical device (in this case DiffMag handheld probe) for clinical use, encountering the new MDR, applicable standards, analyzed risks and adaptations made to the system. Furthermore lessons learned during this process and advice to others to support their development process is given. Chapter 7 provides a general conclusion and future perspectives regarding the magnetic SLNB procedure in OSCC patients and the use of DiffMag handheld probe
| Original language | English |
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| Qualification | Doctor of Philosophy |
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| Award date | 31 Aug 2022 |
| Place of Publication | Enschede |
| Publisher | |
| Print ISBNs | 978-90-365-5411-4 |
| DOIs | |
| Publication status | Published - 31 Aug 2022 |