Abdominal CancerNCT05637359
Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery
An observational study of Abdominal Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
The goal of this observational pilot study is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Cancer
- What is being tested?
- Tracked ultrasound measurement
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jul 2020to 14 Dec 2021
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with cancer in the pelvic-abdominal area, who are scheduled for surgical resection of the malignant tissue in combination with the surgical navigation technique.
Who may be able to join
- Age ≥ 18
- Patients scheduled for tumor surgery in the abdominal/pelvic area and navigation surgery with a scheduled CBCT-scan in the OR
- Patients provide written 'informed consent'
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Netherlands Cancer Institute
Amsterdam, North Holland, 1066 CX
About this study
The goal of this observational pilot study is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation? Participants will undergo tracked ultrasound measurements of the pelvic bone on the operating room after patient anesthesia and before surgical incision.
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. Currently, registration is done by Cone-Beam CT (CBCT) scanning on the operating room (OR) prior to navigation surgery. However, standard CBCT scanning has several limitations, mainly limited availability on the hybrid OR and radiation exposure. Furthermore, standard CBCT scanning can only be performed in horizontal patient position, while the patient position mostly differs during surgery, such as the Trendelenburg position. The use of tracked ultrasound instead of standard CBCT could overcome these limitations, which might lead to an increased navigation accuracy and improved surgical outcomes. Therefore, the goal of this research is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation?
- Conditions
- Abdominal Cancer
- Being tested
- Tracked ultrasound measurement
- Keywords
- Surgical Navigation, Ultrasound, Registration, Electromagnetic Tracking, Pelvic Malignancies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracked ultrasound measurementDevice
Participation in the study will not involve additional visits to the hospital or additional CT scans for the included patients. For this experiment, 2D ultrasound images are obtained using an ultrasound transducer linked to the electromagnetic navigation system, which is already in place for the navigation at the operating room. After anesthesia and in parallel to the final preparations of the patient, two percutaneous ultrasound measurements of the pelvic bone are performed and recorded. The first measurements are performed in Trendelenburg patient position and the second measurements in supine patient position. When preparations are finished, normal workflow is continued, including the standard Cone Beam CT acquisition required for the navigation and sterile draping of the patient.
The acquired ultrasound scans will be analyzed post-operatively and offline. This measurement has no impact on the (navigated) surgical procedure itself.
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for navigated abdominal cancer surgery | Patients are 18 years old or older. Patients are scheduled for tumor surgery in the abdominal/pelvic area and navigation surgery with a scheduled Cone Beam CT-scan in the operating room. Patients provide written 'informed consent'. The to be administered intervention is a percutaneous tracked ultrasound measurement of the patient's pelvic bone on the operating room after anesthesia. Receives: Device: Tracked ultrasound measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of tracked ultrasound registration.
To evaluate the accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. This will be assessed using the target registration error in mm, where a lower error means a better outcome.
Measured: One day
Secondary outcomes (2)
Influence of patient position alteration on registration accuracy.
What is the influence of patient position alteration on the surgical navigation accuracy for standard Cone Beam CT and tracked ultrasound registration methods? This will be assessed using the target registration discrepancy in mm.
Measured: One day
Measurement time of tracked ultrasound registration.
The time duration of ultrasound measurements will be recorded and compared with the conventional Cone Beam CT method. A faster ultrasound measurement time means a better outcome.
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 posted5 Dec 2022
- Study start13 Jul 2020
- Primary completion14 Dec 2021
- Study completion14 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Theo Ruers, prof. dr., Principal investigator, NKI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637359
- Sponsor's protocol ID
- IRBd20-141
- Status last verified
- Nov 2022
- First submitted
- 8 Sep 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hiep MAJ, Heerink WJ, Groen HC, Ruers TJM. Feasibility of tracked ultrasound registration for pelvic-abdominal tumor navigation: a patient study. Int J Comput Assist Radiol Surg. 2023 Sep;18(9):1725-1734. doi: 10.1007/s11548-023-02937-8. Epub 2023 May 25.
PubMed 37227572
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT05637359
- Acronym / sponsor ID
- IRBd20-141
- Conditions
- Abdominal Cancer
- Keywords
- Surgical Navigation, Ultrasound, Registration, Electromagnetic Tracking, Pelvic Malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 14 Dec 2021 (actual)
- Study completion
- 14 Dec 2021 (actual)
- First posted
- 5 Dec 2022 (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.
The goal of this observational pilot study is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation? Participants will undergo tracked ultrasound measurements of the pelvic bone on the operating room after patient anesthesia and before surgical incision.
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. Currently, registration is done by Cone-Beam CT (CBCT) scanning on the operating room (OR) prior to navigation surgery. However, standard CBCT scanning has several limitations, mainly limited availability on the hybrid OR and radiation exposure. Furthermore, standard CBCT scanning can only be performed in horizontal patient position, while the patient position mostly differs during surgery, such as the Trendelenburg position. The use of tracked ultrasound instead of standard CBCT could overcome these limitations, which might lead to an increased navigation accuracy and improved surgical outcomes. Therefore, the goal of this research is to evaluate the feasibility and accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. The main research question is: Could tracked ultrasound be applied as an alternative to standard CBCT scanning in surgical navigation?
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for navigated abdominal cancer surgery | – | Device: Tracked ultrasound measurementPatients are 18 years old or older. Patients are scheduled for tumor surgery in the abdominal/pelvic area and navigation surgery with a scheduled Cone Beam CT-scan in the operating room. Patients provide written 'informed consent'. The to be administered intervention is a percutaneous tracked ultrasound measurement of the patient's pelvic bone on the operating room after anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with cancer in the pelvic-abdominal area, who are scheduled for surgical resection of the malignant tissue in combination with the surgical navigation technique.
Key inclusion criteria (3 listed)
- Age ≥ 18
- Patients scheduled for tumor surgery in the abdominal/pelvic area and navigation surgery with a scheduled CBCT-scan in the OR
- Patients provide written 'informed consent'
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Tracked ultrasound measurementParticipation in the study will not involve additional visits to the hospital or additional CT scans for the included patients. For this experiment, 2D ultrasound images are obtained using an ultrasound transducer linked to the electromagnetic navigation system, which is already in place for the navigation at the operating room. After anesthesia and in parallel to the final preparations of the patient, two percutaneous ultrasound measurements of the pelvic bone are performed and recorded. The first measurements are performed in Trendelenburg patient position and the second measurements in supine patient position. When preparations are finished, normal workflow is continued, including the standard Cone Beam CT acquisition required for the navigation and sterile draping of the patient. The acquired ultrasound scans will be analyzed post-operatively and offline. This measurement has no impact on the (navigated) surgical procedure itself. | Device | Patients scheduled for navigated abdominal cancer surgery |
Primary outcome
Accuracy of tracked ultrasound registration.
Time frame: One day
To evaluate the accuracy of tracked ultrasound registration on patients undergoing abdominal cancer navigation surgery. This will be assessed using the target registration error in mm, where a lower error means a better outcome.
2 secondary outcomes
Influence of patient position alteration on registration accuracy.
Time frame: One day
Measurement time of tracked ultrasound registration.
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Derived from this study: PubMed 37227572Hiep MAJ, Heerink WJ, Groen HC, Ruers TJM. Feasibility of tracked ultrasound registration for pelvic-abdominal tumor navigation: a patient study. Int J Comput Assist Radiol Surg. 2023 Sep;18(9):1725-1734. doi: 10.1007/s11548-023-02937-8. Epub 2023 May 25.
- 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.
Theo Ruers, prof. dr. principal investigator
NKI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 5 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of tracked ultrasound registration. (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05637359, which also lists 1 linked publication.
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 5 Dec 2022.