Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT00722605
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2008-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Respiration-Correlated Cone Beam Computed Tomography (CT) Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-23', 'studyFirstSubmitDate': '2008-07-23', 'studyFirstSubmitQcDate': '2008-07-24', 'lastUpdatePostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To enhance the accuracy of treatment delivery by using a cone-beam CT guided patient positioning procedure, relative to the standard portal image guided procedure.', 'timeFrame': 'conclusion of the study'}], 'secondaryOutcomes': [{'measure': 'To determine the reduction in the proportion of patients with large target positioning errors using the cone-beam CT guided procedure.', 'timeFrame': 'conclusion of the study'}, {'measure': 'To gather data on organ motion and setup errors in the thorax and how they vary over the treatment course, in order to develop efficient clinical correction strategies.', 'timeFrame': 'conclusion of the study'}]}, 'conditionsModule': {'keywords': ['lung', 'esophageal', 'cone beam ct scan'], 'conditions': ['Esophageal Cancer', 'Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan-Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use cone-beam CT scans to more accurately position the tumor during radiation and to see whether this method is more effective than the standard method of using 2D images (portal images), which is a type of X-ray. Cone-beam CT is a type of CT scanner attached to the treatment accelerator that produces 3D images of the patient.\n\nThe ability to eliminate the tumor with radiation depends in part on the accuracy of delivering the radiation to the lung. The position of the tumor changes because of normal breathing. Therefore, we want to improve the accuracy of the way the radiation is delivered to the tumor. With cone-beam CT scans taken before and during your treatment, we will be able to determine the location of the tumor with 3D images, measure how much the tumor moves as you breathe, and then position you so that the tumor will get the best delivery of radiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologic proof of a thoracic malignancy, confirmed at MSKCC and suitable for radiation therapy, in order to be eligible for this study.\n* Patients must be older than 18 years of age\n* At least part of the tumor must be visible as observed in a diagnostic or planning CT. Patients must have Karnofsky Performance Status ≥ 70%\n\nExclusion Criteria:\n\n* Pregnant Women'}, 'identificationModule': {'nctId': 'NCT00722605', 'briefTitle': 'Multiple Respiration-Correlated Cone Beam Computed Tomography (CT) Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'The Use of Multiple Respiration-Correlated Cone Beam CT Scans to Reduce Target Positioning Errors in Radiotherapy Treatment of Thoracic Cancer.', 'orgStudyIdInfo': {'id': '08-080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'cone-beam CT based', 'interventionNames': ['Procedure: cone-beam CT']}], 'interventions': [{'name': 'cone-beam CT', 'type': 'PROCEDURE', 'otherNames': ['The total number of cone-beam CT scans can be between 8 and 10. The scans will take about 15', 'minutes and will occur before your treatment. The scans will help determine whether the', 'radiation is being delivered accurately to the tumor and whether adjustments need to be made.'], 'description': "You will have the following CT scans along with the standard weekly portal images:Before treatment you will have a CT scan (a respiratory-correlated CT scan) at the time of the radiation planning, or simulation planning.During the first week of treatment - you will have 5 cone-beam CT scans at days 1 through 5 of your radiation treatment schedule.\n\n* During the remaining weeks of treatment - you will have a cone-beam CT scan every week. Depending on the number of treatments that your study doctor has prescribed for you, the number of weekly scans can be between 3 and 7.\n* For all scans, an external monitor will be used to record your breathing.\n* If needed, you will be repositioned by adjusting the radiation machine's treatment couch position.", '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': 'Andreas Rimner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}