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Trial Title:
Image-guided Navigation During Robotic Sentinel Node Removal
NCT ID:
NCT06091072
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
One group to evaluate the feasibility of the proposed method.
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Image-guided navigation
Description:
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.
Arm group label:
Patients scheduled for sentinel node procedure
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.
Detailed 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.
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Netherlands Cancer Institute
Address:
City:
Amsterdam
Zip:
1066CX
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Laura Aguilera Saiz, MSc
Phone:
+31205127491
Email:
l.aguilera@nki.nl
Investigator:
Last name:
Laura Aguilera Saiz, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Theo Ruers, Prof. Dr.
Email:
Principal Investigator
Investigator:
Last name:
Wout Heerink, Dr.
Email:
Sub-Investigator
Investigator:
Last name:
Harald Groen, Dr.
Email:
Sub-Investigator
Start date:
July 1, 2021
Completion date:
August 1, 2024
Lead sponsor:
Agency:
The Netherlands Cancer Institute
Agency class:
Other
Source:
The Netherlands Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06091072
