Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2025-12-28 @ 10:09 PM
Study NCT ID:
NCT01971866
Status:
TERMINATED
Last Update Posted:
2016-01-27
First Post:
2013-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Camera Based System to Monitor Patient Movement During Radiation Treatment
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': 1}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Slow enrollment, feasibility issues', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2013-10-17', 'studyFirstSubmitQcDate': '2013-10-23', 'lastUpdatePostDateStruct': {'date': '2016-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Paired difference between image accuracy plan data from the AlignRT system compared to the current x-ray based imaging system.', 'timeFrame': '3 months', 'description': 'Enrollment and analysis will be restricted to adult patients with tumors of the brain, head and neck region, thorax, upper abdomen, or posterior spine/sacrum. Primary outcome will be analyzed by paired t-test.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Proton radiation', 'AlignRT'], 'conditions': ['Set up and Monitoring of Patients Receiving Proton Radiation']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the advantages of using AlignRT, a commercially available, FDA approved camera-based imaging system for proton therapy patients prior to and during their radiation treatment delivery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are undergoing proton radiation therapy at UFPTI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with tumors of the brain, head and neck, thorax, upper abdomen, posterior spine/sacrum and extremities'}, 'identificationModule': {'nctId': 'NCT01971866', 'acronym': 'DS02', 'briefTitle': 'Camera Based System to Monitor Patient Movement During Radiation Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Improving Safety and Accuracy of Proton Therapy by Use of Camera-Based Patient Localization System', 'orgStudyIdInfo': {'id': 'UFPTI 1215-DS02'}}, 'contactsLocationsModule': {'locations': [{'zip': '32206', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida Proton Therapy Institute', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Maria Mamalui-Hunter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida Proton Therapy Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}