Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-26 @ 1:32 PM
Study NCT ID:
NCT05637359
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2022-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-24', 'studyFirstSubmitDate': '2022-09-08', 'studyFirstSubmitQcDate': '2022-11-24', 'lastUpdatePostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of tracked ultrasound registration.', 'timeFrame': 'One day', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Influence of patient position alteration on registration accuracy.', 'timeFrame': 'One day', 'description': '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.'}, {'measure': 'Measurement time of tracked ultrasound registration.', 'timeFrame': 'One day', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Surgical Navigation', 'Ultrasound', 'Registration', 'Electromagnetic Tracking', 'Pelvic Malignancies'], 'conditions': ['Abdominal Cancer']}, 'referencesModule': {'references': [{'pmid': '37227572', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18\n* Patients scheduled for tumor surgery in the abdominal/pelvic area and navigation surgery with a scheduled CBCT-scan in the OR\n* Patients provide written 'informed consent'\n\nExclusion Criteria:\n\n* No exclusion criteria"}, 'identificationModule': {'nctId': 'NCT05637359', 'briefTitle': 'Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Netherlands Cancer Institute'}, 'officialTitle': 'Tracked Ultrasound for Patient Registration in Surgical Navigation During Abdominal Cancer Surgery', 'orgStudyIdInfo': {'id': 'IRBd20-141'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients scheduled for navigated abdominal cancer surgery', 'description': "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.", 'interventionNames': ['Device: Tracked ultrasound measurement']}], 'interventions': [{'name': 'Tracked ultrasound measurement', 'type': 'DEVICE', 'description': '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.\n\nThe acquired ultrasound scans will be analyzed post-operatively and offline. This measurement has no impact on the (navigated) surgical procedure itself.', 'armGroupLabels': ['Patients scheduled for navigated abdominal cancer surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1066 CX', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Netherlands Cancer Institute', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Theo Ruers, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NKI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Netherlands Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}