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Patients are 18 years old or older. Patients are scheduled for tumor surgery in the abdominal/pelvic area and navigation surgery with a scheduled Cone Beam CT-scan in the operating room. Patients provide written 'informed consent'. The to be administered intervention is a percutaneous tracked ultrasound measurement of the patient's pelvic bone on the operating room after anesthesia.

Participation in the study will not involve additional visits to the hospital or additional CT scans for the included patients. For this experiment, 2D ultrasound images are obtained using an ultrasound transducer linked to the electromagnetic navigation system, which is already in place for the navigation at the operating room. After anesthesia and in parallel to the final preparations of the patient, two percutaneous ultrasound measurements of the pelvic bone are performed and recorded. The first measurements are performed in Trendelenburg patient position and the second measurements in supine patient position. When preparations are finished, normal workflow is continued, including the standard Cone Beam CT acquisition required for the navigation and sterile draping of the patient.

The acquired ultrasound scans will be analyzed post-operatively and offline. This measurement has no impact on the (navigated) surgical procedure itself.

Tracked ultrasound measurement

Theo Ruers, prof. dr.

The goal of this observational pilot study is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation? Participants will undergo tracked ultrasound measurements of the pelvic bone on the operating room after patient anesthesia and before surgical incision.

Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery and has the potential of reducing both irradical resections and morbidity. Currently, registration is done by Cone-Beam CT (CBCT) scanning on the operating room (OR) prior to navigation surgery. However, standard CBCT scanning has several limitations, mainly limited availability on the hybrid OR and radiation exposure. Furthermore, standard CBCT scanning can only be performed in horizontal patient position, while the patient position mostly differs during surgery, such as the Trendelenburg position. The use of tracked ultrasound instead of standard CBCT could overcome these limitations, which might lead to an increased navigation accuracy and improved surgical outcomes. Therefore, the goal of this research is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation?

Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery

To evaluate the accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. This will be assessed using the target registration error in mm, where a lower error means a better outcome.

What is the influence of patient position alteration on the surgical navigation accuracy for standard Cone Beam CT and tracked ultrasound registration methods? This will be assessed using the target registration discrepancy in mm.

The time duration of ultrasound measurements will be recorded and compared with the conventional Cone Beam CT method. A faster ultrasound measurement time means a better outcome.

The Netherlands Cancer Institute

This is a single-center observational feasibility study to develop an automatic segmentation and registration algorithm based on ultrasound imaging of the pelvic arteries. The duration of this study will be approximately 1 year. Patients scheduled for a laparotomy at the NKI are eligible for inclusion. Patients are informed about the study before the planned surgery and, after being provided with the necessary information regarding participation in the study, will be asked for informed consent. The ultrasound acquisitions for this study will be performed intra-operatively with CE marked equipment for intra-operative ultrasound. There is no impact on the standard surgical procedure or decision making of the surgery. After surgery, no further participation or cooperation of the patient is required.

A patient-specific 3D model will be created using an available pre-operative CT scan. Anatomical target points are selected on this virtual model before the start of the surgery. Prior to surgery, a patient-reference electromagnetic (EM) sensor will be placed between the patient and the matrass on the operating table to account for patient movement during acquisition. Intra-operatively, an initial point registration of the 3D model with the electromagnetic tracking system (EMTS) will be performed based on ultrasound (US) imaging of the arterial bifurcations by the surgeon. Then, the surgeon will acquire multiple US sweeps of the pelvic arteries (abdominal aorta and left and right iliac arteries). For validation purposes, the pre-operatively defined anatomical target points will be visualized on US imaging and by pinpointing the EM tracked pointer. All tracking and US data will be recorded and stored for post-operative analysis.

Intra-operative ultrasound measurement

Marijn Hiep, MSc

Theo Ruers, Prof. Dr.

Wout Heerink, Dr.

Harald Groen, Dr.

In this study we aim to develop an automatic pelvic artery segmentation algorithm, which is required for future clinical implementation of US registration for surgical navigation. Various registration methods will be evaluated with the data of this study to obtain most optimal results. If automatic segmentation and registration is successful, the final accuracy of the developed US registration method for tumor tracking should be evaluated in future studies in patients eligible for surgical navigation. Eventually, we aim to replace the CBCT-scan with an automatic tracked US registration pipeline for a more efficient and accurate registration procedure, which could improve the applicability and accuracy of surgical navigation and patient outcomes.

Image-guided navigation surgery allows for full utilization of pre-operative imaging during surgery and has the potential of reducing both irradical resections and morbidity. To use navigation, a registration procedure is required to correlate pre-operative imaging with the patient's position on the operating room (OR). Currently, registration is done by Cone-Beam CT (CBCT) scanning on the OR prior to navigation surgery. However, the main limitation of the CBCT method is that it cannot compensate for per-operative changes such as bed rotation, retractor placement and tissue displacement due to the surgery. Alternatively, by using intra-operative tracked ultrasound and vessel-based patient registration, changing conditions during surgery can better be dealt with. This improved patient registration method could lead to an increased navigation accuracy and improved clinical usability and outcomes.

The main difference between CBCT and proposed ultrasound registration is that CBCT is based on bones, while the ultrasound is based on vessels. Bones can be very easily imaged on the CBCT and therefore used for bone-bone registration with pre-operative CT-scans. However, vessels are more difficult to acquire, especially with ultrasound, and an automatic registration process with pre-operative imaging is needed for efficient clinical usability. For this, the vessels need to be extracted from the tracked ultrasound images to create a 3D representation that can be registered. Therefore, an algorithm needs to be developed that can automatically segment the pelvic vessels from ultrasound images.

One group to evaluate the feasibility and accuracy of the proposed methods.

Vessel-based Ultrasound Registration

Intra-operative Pelvic Vessel Acquisition, Towards Ultrasound Registration for Surgical Navigation

An automatic segmentation algorithm for real-time intra-operative pelvic vessel segmentation from tracked US images will be developed. The accuracy of this network will be evaluated using the Dice similarity coefficient, ranging from 0 to 1 where a higher score means a better outcome.

To evaluate the accuracy of different patient registration methods of intra-operative US imaging with pre-operative CT imaging, such as 3D model or centerline registration.

Evaluation of the intraoperative usability of the tracked US device and visualization of pelvic vessels by the surgeons will be evaluated using the system usability scale (SUS). This scale ranges from 0-100 where a higher score means a better outcome.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery	NCT05637359	Abdominal Cance...	Tracked ultraso...	18 Years -	The Netherlands Cancer Institute
Vessel-based Ultrasound Registration	NCT05637346	Abdominal Cance...	Intra-operative...	18 Years -	The Netherlands Cancer Institute
Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery	NCT05637359	Abdominal Cance...	Tracked ultraso...	18 Years -	The Netherlands Cancer Institute
Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery	NCT05637359	Abdominal Cance...	Tracked ultraso...	18 Years -	The Netherlands Cancer Institute
Vessel-based Ultrasound Registration	NCT05637346	Abdominal Cance...	Intra-operative...	18 Years -	The Netherlands Cancer Institute

Spots Global Cancer Trial Database for pelvic malignancies