Clinical Research Funding of the University of Oldenburg and partially self-funded by the University Hospital for Urology
The project started in early 2015. After finalisation of the analysis plan, the evaluation of the data will be carried out by the Division of Epidemiology and Biometry.
The Division of Epidemiology and Biometry supports the University Hospital for Urology with the planning and evaluation of a clinical study and a project concerning the care and epidemiology of prostate cancer.
The clinical study focuses on a new optical diagnostic method used for the targeted marking and removal of sentinel lymph nodes of prostate cancer.
The magneto-meter guided intra-operative detection of sentinel lymph nodes after trans-rectal injection of superparamagnetic injection of iron oxide nanoparticles is a promising new method for the targeted removal of lymph nodes. Thus, it could become an alternative to radioactive marking with technetium-nanocolloid and detection with the help of a gamma-probe, which offers a high sensitivity in picking up metastases, but has its disadvantages such as exposure of the patient and medical staff to radiation, the availiability of radioactive tracers and nuclear-medical logistics.
For breast cancer, studies have already shown that results based on the magnetic marking technique are comparable to those based on the conventional one. A worldwide first study using this technique (SentiMagPro) for prostate cancer has shown the applicability and functionality of this procedure on the prostate (Winter et al., 2014).
In the current study (SentiMagPro II) the results of the magneto-meter guided sentinel detection after transrectal injection of the superparamagnetic tracers in the prostate will be exploratively analysed. In particular, the aim is to assess if detection rate and sensitivity of this new diagnostic procedure are comparable to the standard radioactive marking and detection based on the gammaprobe.
The collection and documentation of the clinical data will be carried out with an internet-based information system, which has been developed by the Oldenburg Institute for Information Technology (OFFIS), in cooperation with the University Hospital for Urology, and will later be further modified and used within a multicenter study.