gynecological cancer tumors in the vagina or cervix Tumors in the vagina or cervix
Conditions
Interventions
The placement of the catheters is performed according to 
standard clinical care. A custom-developed stylet inside the 
standard freehand catheters is tracked and can thus be used to visualize the 
catheters in real-time relative to the tracked cylinder / applicator. The radiotherapist uses 
cone beam CT when desired to validate brachy catheter placement, as during the 
standard procedure.
Sponsors
Antoni van Leeuwenhoek (AVL)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the number of successful catheter placements in a navigated brachytherapy catheter placement procedure to that number in a procedure without navigation. Out of the total of 18 procedures, 9 will be navigated an 9 will not be navigated, alternating between fractions for each patient (meaning every patient gets navigation for either the first and third fraction or only the second fraction).To determine if a catheter is placed successfully, a preoperatively defined plan* is registered to the brachy planning MRI* with the placed catheters. The accuracy of catheter placement is defined as the distance d between the registered preoperatively defined planned catheters and the actual positions of the catheters in the MRI. *The preoperative plan is based on the MRI that is standardly acquired in the week before the first fraction brachytherapy. * The brachytherapy planning MRI is acquired directly after the catheter insertion and is used to plan the brachytherapy dose based on the inserted catheters. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): • To evaluate easiness of use and support for decisiveness during surgery using stand-ardized System Usability Scale (SUS) questionnaires. • To evaluate the accuracy of the MRI/US registration with the target registration error. • To evaluate the time of all study-related actions during the surgery. • To evaluate the difference between the planned catheter path and actual catheter path. | — |
Countries
Netherlands
Contacts
Public ContactLPJ Venix
Antoni van Leeuwenhoek (AVL)
Outcome results
None listed