Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2025-12-25 @ 7:58 PM
Study NCT ID:
NCT00582959
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of Cone Beam Imaging for Radiation Therapy Treatment Verification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-05', 'studyFirstSubmitDate': '2007-12-20', 'studyFirstSubmitQcDate': '2007-12-27', 'lastUpdatePostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obtain multiple (1-5) 3DCBIs on patients during the course of their radiation therapy treatments using a prototype megavoltage (MV) system and determine if the prototype imaging system is reliable and practical for routine clinical portal imaging.', 'timeFrame': 'conclusion of the study'}], 'secondaryOutcomes': [{'measure': 'For some patients, in addition to obtaining 1-5 MV conebeam scans, obtain 1-2 conebeam scans using a new kilovoltage conebeam imaging system', 'timeFrame': 'conclusion of the study'}, {'measure': 'Compare the quality and utility of the MV and kV conebeam systems.', 'timeFrame': 'conclusion of the study'}]}, 'conditionsModule': {'keywords': ['radiology imaging', 'malignancy', 'undergoing radiation therapy'], 'conditions': ['Radiation Treatment for Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test a new technology for obtaining x-ray images of your treatment fields when you are positioned on the treatment machine, to determine whether this new system is as reliable and easy to use as conventional systems.. These so-called portal images are normally taken on a weekly basis, prior to your radiation treatment. The new portal imaging system to be tested is designed to produce better quality images than are currently achievable, but with no additional dose or added treatment time.', 'detailedDescription': 'The objective of this proposal is to test the clinical practicality of a new technology; cone beam imaging, for verification of treatment set up accuracy of cancer patients receiving radiation therapy. Currently, treatment accuracy is checked via use of 2-dimensional projection x-rays taken with the megavoltage treatment beam and electronic portal imaging devices (EPID). Typically 2 orthogonal portal images are obtained to confirm patient positioning accuracy. This method of treatment verification, however, usually provides images of poor quality and lacks true 3D information, thus making it difficult for the radiation oncologist to definitively confirm treatment accuracy. New generation EPIDs are capable of obtaining higher quality images at significantly lower imaging doses. Thus, for the same total imaging dose new generation EPIDs permit acquisition of many projection images rather than just 2 or 3. The combination of more images and higher quality images should permit more definitive assessment of treatment accuracy. We propose here to test the clinical practicality and reliability of a new prototype portal imaging system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologic proof of a malignancy suitable for radiation therapy in order to be eligible for this study\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT00582959', 'briefTitle': 'Feasibility Study of Cone Beam Imaging for Radiation Therapy Treatment Verification', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Feasibility Study of Cone Beam Imaging for Radiation Therapy Treatment Verification', 'orgStudyIdInfo': {'id': '04-037'}, 'secondaryIdInfos': [{'id': 'NCI CA59017'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Prototype, third generation EPID based portal imaging system utilizing the MV approach.', 'interventionNames': ['Other: Cone Beam Imaging']}], 'interventions': [{'name': 'Cone Beam Imaging', 'type': 'OTHER', 'description': 'Prototype, third generation EPID based portal imaging system utilizing the MV approach.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Michael Zelefsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}