Electromagnetic-Guided Interstitial Catheter Navigation for Gynecological Brachytherapy: a Phase I Trial (E-MINT)

Catheter insertion for gynecological interstitial brachytherapy is a challenging surgical procedure due to the lack of real-time guidance available to Radiation Oncologists. To mitigate the limitations associated with catheter placement, electromagnetic navigation (EMN) was proposed as a solution to the current interstitial brachytherapy workflow. The sequence of events leading up to the completion of this project were as follows, the validation of the system and then the application of the EMN system in a clinical trial. Using a phantom-based validation method, submillimetric accuracy and jitter was characterized for the operational performance of an EMN system in a brachytherapy operating room environment.

Following validation, the EMN system was used for catheter placement in 5 patients, in an ongoing prospective clinical study. The mean catheter deflection documented was 3.52 +/- 2.53 mm when adopting EMN as a form of real-time guidance compared to 5.48 +/- 3.63 mm when the standard clinical workflow (SCW) was employed. The mean catheter spacing when using EMN was 9.31 +/- 4.81 mm compared to 7.09 +/- 6.06 mm when the SCW was followed. Also, the mean intraoperative time was 50.00 +/- 18.80 minutes for EMN and 38.20 +/- 15.29 minutes for the SCW.

The results of this project demonstrate that electromagnetic navigated interstitial catheter placement is promising as a real-time guidance option for the interstitial gynecological brachytherapy workflow.