The primary objective of this study is to assess the feasibility of EM-navigation for gynaecological brachytherapy catheter placement.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Vulvovaginal disorders (excl infections and inflammations)
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the feasibility of image guided navigation with
EM-tracking for assistance during gynaecologic brachytherapy catheter
placement. Feasibility is defined as a successful when 80% of the navigations
are successful.
A navigation is successful when the fiducial root mean square error (RMSE) for
gold marker MRI to US registration is below 5 mm.
Secondary outcome
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.
Background summary
Image-guided navigation surgery allows for optimal use and full integration of
3D models based on patient-specific anatomy. Image-guided techniques have
proven to be useful for localization and visualization of lesions, and might be
of use for gynecological brachytherapy catheter placement, especially for
freehand catheters. This is the first feasibility study where electromagnetic
(EM)-tracking is used for real-time navigated gynecological brachytherapy (BT)
catheter placement.
Study objective
The primary objective of this study is to assess the feasibility of
EM-navigation for gynaecological brachytherapy catheter placement.
Study design
A single centre feasibility study.
Intervention
The placement of the gold markers (GMs) and catheters is performed according to
standard clinical care. Tumor registration is performed using the standard
transrectal ultrasound transducer. 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 3D MRI model. The radiotherapist uses
cone beam CT when desired to validate brachy catheter placement, as during the
standard procedure.
Study burden and risks
Participation in the study will not involve additional visits to the hospital
for the included patients. Patients will be informed about the study during the
pre-operative outpatient clinic appointment. Informed consent will be obtained
during one of the patients visits to the hospital. Catheter placement takes
place with conventional decision making, by using ultrasound and cone beam CT.
The radiotherapists are aware of the experimental setup, and are therefore
responsible for the navigation interpretation and actions. During the
procedure, the accuracy of the registration is assessed by checking the overlap
of MRI and ultrasound anatomy (bladder, cervix, etc.). The ultimate goal of
this project is to judge the potential use of the navigation setup for further
gynecological BT catheter placement procedures. A maximal delay of 15 minutes
will be added to the total time of the surgical procedure.
Plesmanlaan 121A
Amsterdam 1066CX
NL
Plesmanlaan 121A
Amsterdam 1066CX
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84035.041.23 |