Image-guided Navigation During Robotic Sentinel Node Removal

NCT06091072 | Unknown

• 1 other identifier: NL77462.031.21
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Usability of image-guided navigation

  One day

• Time

  One day

Study Arms (1)

Patients scheduled for sentinel node procedure

EXPERIMENTAL

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.

Other: Image-guided navigation

Interventions

Image-guided navigation OTHER

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.

Patients scheduled for sentinel node procedure

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Metal hip implants / implants in the pelvic area
• Pacemaker, defibrillator

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surgery, Computer-Assisted

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Laura Aguilera Saiz, MSc

CONTACT

+31205127491; l.aguilera@nki.nl

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 of the proposed method.

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: July 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)