The feasibility of electromagnetic tracking for navigated placement of gynecological brachytherapy catheters

Conditions: gynecological cancer
tumors in the vagina or cervix
10038594
10047789
10029903

Registration Number: NL-OMON53248

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:

1. Age >= 18 years
2. Patient or legal representative provides written informed consent form
3. Patient is scheduled for intrauterine brachytherapy application with one or
more free-hand catheters additional to the catheters through the applicator

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded
from participation in this study:

- Ferro-magnetic implants in the abdominal or pelvic area that could influence
EM tracking;
- No gold markers implanted, gold markers fallen out or gold markers not
visible on intraoperative ultrasound imaging.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the feasibility of image guided navigation with<br /><br>EM-tracking for assistance during gynaecologic brachytherapy catheter<br /><br>placement. Feasibility is defined as a successful when 80% of the navigations<br /><br>are successful.<br /><br>A navigation is successful when the fiducial root mean square error (RMSE) for<br /><br>gold marker MRI to US registration is below 5 mm. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Objective(s):<br /><br>• To evaluate easiness of use and support for decisiveness during surgery using<br /><br>stand-ardized System Usability Scale (SUS) questionnaires.<br /><br>• To evaluate the accuracy of the MRI/US registration with the target<br /><br>registration error.<br /><br>• To evaluate the time of all study-related actions during the surgery.<br /><br>• To evaluate the difference between the planned catheter path and actual<br /><br>catheter path. </p><br>