Clinical trial · Interventional
Image-guided Navigation During Robotic Sentinel Node Removal
Feasibility of in Vivo Image-guided Navigation During Robotic Sentinel Node Removal
- 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)
Image-guided navigation based on pre-operative imaging can give the surgeon more insight into the location of the sentinel nodes in relation to other anatomical structures. The purpose of the study is to investigate the feasibility of image-guided navigation during robot-assisted surgery to treat cancer in the pelvic area.Ultimately, the application of navigation during robot-assisted sentinel node dissection could potentially improve the outcome of surgery for the patient.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Image-guided navigation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients scheduled for sentinel node procedure
- description
- This is a single-center observational feasibility study to evaluate the overall performance of the surgical navigation system during robotic surgery, without impact on the surgical procedure itself. The duration of this study will be approximately 2.5 years. Patients scheduled for a sentinel node procedure 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. No additional risk is expected using the NDI navigation setup. Patients will receive some additional radiation due to the CT scan during surgery; a perioperative CBCT scan (\~ 4 mSv) is acquired. This extra dose is low, considering other standard imaging in these patients like, pre-operative imaging with SPECT/CT scans. After surgery, no further participation or cooperation of the patient is required.
- interventionNames
- Other: Image-guided navigation
Primary outcomes (1)
- measure
- Feasibility of image-guide assisted sentinel node removal
- timeFrame
- One day
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Scheduled for abdominal robotic sentinel node resection * ≥ 18 years old * Provided written 'informed consent' * Sentinel nodes should be fixed relative to retroperitoneal structures or major vessels. Exclusion Criteria: * Metal hip implants / implants in the pelvic area * Pacemaker, defibrillator
References
Publications (0)
Data not yet available