Image-guided Navigation During Robotic Sentinel Node Removal

Prostate Cancer Clinical Trial

— N21LND  

Official title:

Feasibility of in Vivo Image-guided Navigation During Robotic Sentinel Node Removal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091072
• Other study ID #: NL77462.031.21
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: August 1, 2024

Study information

• Verified date: October 2023
• Source: The Netherlands Cancer Institute
• Contact: Laura Aguilera Saiz, MSc
• Phone: +31205127491
• Email: l.aguilera[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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. It has successfully been applied in the AvL for open abdominal surgery, however more and more surgeries are being performed less invasive using robot surgery. Rapid extension of robot-assisted surgery has increased the need for robot-compliant image-guided techniques. Unfortunately, tactile feedback is lacking in these robotic surgeries, which increases the additional value of image-guided navigation. In this study, patients will undergo an abdominal sentinel node dissection in order to evaluate the actual technical benefit of robotic navigation. This is the first feasibility study towards clinical implementation of the navigation setup into robot-assisted image-guided navigation surgery. The results of this study will be the base for new studies, evaluating the clinical benefit of image-guided navigation for robot surgeries.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Image-guided navigation
A patient-specific 3D model will be created using an available pre-operative SPECT/CT scan. Pre-operatively, three electromagnetic patient trackers will be attached to the patients' skin, close to the pelvis, allowing tracking the patient's position during surgery. After anesthesia and before the skin disinfection procedure, the patient is placed in the final surgical position, where an intra-operative CBCT scan is performed required for the image-guided surgery workflow. During surgery, the preoperative images and 3D model will be visible for the surgeon together with a blunt-tip electromagnetic pointer enabling surgical navigation during robotic surgery. Anatomical structures will be used to validate the accuracy of the navigation. When the target is identified by the surgeon, the pointer is used to store the location digitally. Scheduled standard clinical 99mTc will be used as validation for target(s) identification.

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	Feasibility of image-guide assisted sentinel node removal	The percentage of successful image-guide assisted sentinel nodes removed, in which failure is defined as sentinel nodes which are per-operatively incorrectly identified as target SN by the navigation.	One day
Secondary	Usability of image-guided navigation	Evaluation of the usability of the image-guided navigation 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
Secondary	Time	Time to localization and removal of the sentinel node and total surgical time will be recorded.	One day