Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-28 @ 8:52 AM
Study NCT ID:
NCT07116759
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Head Stabilization of Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Rodney.Wiersma@pennmedicine.upenn.edu', 'phone': '773-623-9820', 'title': 'Rodney Wiersma, PhD', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year and 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Volunteers', 'description': "The volunteer population will consist of healthy individuals.\n\nReal-time head stabilization with robotic platform: A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive.", 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': "The volunteer population will consist of healthy individuals.\n\nReal-time head stabilization with robotic platform: A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive."}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One-time session, up to 4 hours on a single day.', 'description': 'Real-time intracranial target motion was continuously monitored using a commercial surface-guided radiation therapy (SGRT) system operating at approximately 10 frames per second. For each participant, translational (mm) and rotational (degree) motion of the target were computed relative to the starting head position at setup. The target position was tracked in six degrees of freedom (longitudinal, lateral, vertical translation; pitch, roll, yaw rotation). To provide a quantitative endpoint reflecting system effectiveness, the recorded 6D target motion data were analyzed and positional deviation histograms showing the total percentage of time that the target remained below a specific translational and rotational tolerance level were generated. The percentage of time that the target remained below a tolerance of \\< 1.0 mm translational and \\< 1.0° rotational deviation was chosen as the single primary outcome measure.', 'unitOfMeasure': '% of time within tolerance', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '18 healthy volunteers, who successfully completed simulating in a clinical environment but without delivering radiation'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Volunteers', 'description': "The volunteer population will consist of healthy individuals.\n\nReal-time head stabilization with robotic platform: A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Incompatibility with the RHMC device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Volunteers', 'description': "The volunteer population will consist of healthy individuals.\n\nReal-time head stabilization with robotic platform: A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-14', 'size': 290741, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-29T11:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-08-07', 'resultsFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-08-07', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-17', 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collection of Head Motion Data to be Used in Developing Head Stabilization Methods in Brain Radiation Patients', 'timeFrame': 'One-time session, up to 4 hours on a single day.', 'description': 'Real-time intracranial target motion was continuously monitored using a commercial surface-guided radiation therapy (SGRT) system operating at approximately 10 frames per second. For each participant, translational (mm) and rotational (degree) motion of the target were computed relative to the starting head position at setup. The target position was tracked in six degrees of freedom (longitudinal, lateral, vertical translation; pitch, roll, yaw rotation). To provide a quantitative endpoint reflecting system effectiveness, the recorded 6D target motion data were analyzed and positional deviation histograms showing the total percentage of time that the target remained below a specific translational and rotational tolerance level were generated. The percentage of time that the target remained below a tolerance of \\< 1.0 mm translational and \\< 1.0° rotational deviation was chosen as the single primary outcome measure.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': "A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive and since healthy volunteers are enrolled in this study, no radiation is delivered, but in the future, the investigators plan to use this device during radiation treatment with patients.", 'detailedDescription': 'This study aims to passively monitor the real-time head motions of healthy volunteers positioned to simulate whole brain radiation therapy. Such real-time head motion data is necessary in order to understand the type (amplitude/frequency) of motion that the robotic stage will be expected to compensate for and will play an important role in the overall modeling and designing process of the robotic prototype.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The volunteer population will consist of healthy individuals.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects 18 and older\n* Subjects must be able to read and understand English\n* Participants must sign the informed consent form\n\nExclusion Criteria:\n\nAny subjects not meeting the above inclusion criteria will not be considered for this study.'}, 'identificationModule': {'nctId': 'NCT07116759', 'briefTitle': 'Head Stabilization of Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Real-Time Head Position Stabilization of Healthy Volunteers', 'orgStudyIdInfo': {'id': 'UPCC 07325'}, 'secondaryIdInfos': [{'id': 'R01CA227124-02', 'link': 'https://reporter.nih.gov/quickSearch/R01CA227124-02', 'type': 'NIH'}, {'id': '843058', 'type': 'OTHER', 'domain': 'University of Pennsylvania Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Volunteers', 'description': 'The volunteer population will consist of healthy individuals.', 'interventionNames': ['Device: Real-time head stabilization with robotic platform']}], 'interventions': [{'name': 'Real-time head stabilization with robotic platform', 'type': 'DEVICE', 'description': "A robotic platform will use data from motion-detection cameras to position a person's head in real time. This procedure is non-invasive.", 'armGroupLabels': ['Healthy Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Rodney Wiersma, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}