Vessel-based Ultrasound Registration

Abdominal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05637346
• Other study ID #: N21VUR
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2022
• Source: The Netherlands Cancer Institute
• Contact: Marijn Hiep, MSc
• Phone: +31205121751
• Email: ma.hiep[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years old
• Scheduled for laparotomy
• A clinical pre-operative abdominal CT scan is available
• Patient provides written informed consent

Exclusion Criteria:

• Metal implants in the pelvic area which could influence the 3D modelling or tracking accuracy
• Patients with a pacemaker or defibrillator
• Patient received pelvic-abdominal treatment, e.g. surgery or radiotherapy, between the pre-operative CT scan and laparotomy, which might altered the patient's anatomy

Related Conditions & MeSH terms

• Abdominal Cancer

Intervention

Procedure:
• Intra-operative ultrasound measurement
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.

Locations

Country	Name	City	State
Netherlands	Netherlands Cancer Institute	Amsterdam	North Holland

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of developed automatic segmentation algorithm	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.	One day
Secondary	Accuracy of intra-operative ultrasound registration	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.	One day
Secondary	Usability of intra-operative ultrasound 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.	One day