Vessel- and Bone-based Ultrasound Registration

NCT05637346 | Completed

• 1 other identifier: N21VUR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Cancer

Keywords

Surgical Navigation; Ultrasound; Registration; Electromagnetic Tracking; Pelvic Malignancies; Deep Learning; Segmentation

Outcome Measures

Primary Outcomes (1)

• Accuracy of developed automatic segmentation algorithm

  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.

  One day

Secondary Outcomes (2)

• Accuracy of intra-operative ultrasound registration

  One day

• Usability of intra-operative ultrasound registration

  One day

Study Arms (1)

Patients scheduled for laparotomy

EXPERIMENTAL

This is a single-center observational feasibility study to develop an automatic segmentation and registration algorithm based on ultrasound imaging of the arteries and bones. The duration of this study will be approximately 2 years. Patients scheduled for a laparotomy or robotic assisted lymph node dissection 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.

Procedure: Intra-operative ultrasound measurement

Interventions

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.

Patients scheduled for laparotomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Related Publications (1)

• Hiep MAJ, Heerink WJ, Groen HC, Saiz LA, Grotenhuis BA, Beets GL, Aalbers AGJ, Kuhlmann KFD, Ruers TJM. Real-time intraoperative ultrasound registration for accurate surgical navigation in patients with pelvic malignancies. Int J Comput Assist Radiol Surg. 2025 Feb;20(2):249-258. doi: 10.1007/s11548-024-03299-5. Epub 2024 Dec 4.

  PMID: 39633142 RESULT

Study Officials

• Theo Ruers, prof. dr.

  NKI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: December 5, 2022
• Study Start: December 5, 2021
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)