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Completed

NCT Number: NCT05637346

Vessel- and Bone-based Ultrasound Registration

In this study we aim to develop an automatic artery and bone 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.

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Key information

Conditions

Abdominal Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years old
  • Scheduled for laparotomy (first 30 patients) or robotic assisted lymph node dissection (second 20 patients)
  • A clinical pre-operative CT scan is available
  • Patient provides written informed consent

Exclusion criteria

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

Treatment and study plan

Intra-operative ultrasound measurement

Procedure

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 bone (pubic bone, sacrum and iliac crests) and 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.

Primary outcomes

  1. Accuracy of developed automatic segmentation algorithm

    Time frame: One day

    An automatic segmentation algorithm for real-time intra-operative vessel and bone 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.

Secondary outcomes

  1. Accuracy of intra-operative ultrasound registration

    Time frame: One day

    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.

  2. Usability of intra-operative ultrasound registration

    Time frame: One day

    Evaluation of the intraoperative usability of the tracked US device and visualization of vessels and bone 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.

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2022
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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