Prostate CancerN21LNDNCT06091072
Image-guided Navigation During Robotic Sentinel Node Removal
A study testing Image-guided navigation in people with Prostate Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Image-guided navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Metal hip implants / implants in the pelvic area
- Pacemaker, defibrillator
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Netherlands Cancer Institute
Amsterdam, North Holland, 1066CX
Laura Aguilera Saiz, MSc, +31205127491, l.aguilera@nki.nl
Laura Aguilera Saiz, MSc
About this study
Official title: Feasibility of in Vivo Image-guided Navigation During Robotic Sentinel Node Removal
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Image-guided navigation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-guided navigationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Image-guided navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Secondary outcomes (2)
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.
Measured: One day
Time
Time to localization and removal of the sentinel node and total surgical time will be recorded.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Jul 2021
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group to evaluate the feasibility of the proposed method.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091072
- Sponsor's protocol ID
- NL77462.031.21
- Acronym
- N21LND
- Status last verified
- Oct 2023
- First submitted
- 13 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of in Vivo Image-guided Navigation During Robotic Sentinel Node Removal
- ClinicalTrials.gov ID
- NCT06091072
- Acronym / sponsor ID
- N21LND / NL77462.031.21
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group to evaluate the feasibility of the proposed method.
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for sentinel node procedure | Experimental | Other: Image-guided navigationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Metal hip implants / implants in the pelvic area
- Pacemaker, defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image-guided navigationA 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. | Other | Patients scheduled for sentinel node procedure |
Primary outcome
Feasibility of image-guide assisted sentinel node removal
Time frame: One day
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.
2 secondary outcomes
Usability of image-guided navigation
Time frame: One day
Time
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image-guided navigation in people with Prostate Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Aguilera Saiz, MSc (+31205127491, l.aguilera@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of image-guide assisted sentinel node removal (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.