Clinical trial · Interventional
Vessel- and Bone-based Ultrasound Registration
Intra-operative Vessel and Bone Acquisition, Towards Ultrasound Registration for Surgical Navigation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Cancer | Malignant Abdominal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-operative ultrasound measurement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients scheduled for laparotomy
- description
- 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.
- interventionNames
- Procedure: Intra-operative ultrasound measurement
Primary outcomes (1)
- measure
- Accuracy of developed automatic segmentation algorithm
- timeFrame
- One day
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTHiep 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