Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT00980993
Status:
WITHDRAWN
Last Update Posted:
2019-11-04
First Post:
2009-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantification of Respiratory-induced Prostate Motion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of enrollment.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-31', 'studyFirstSubmitDate': '2009-09-19', 'studyFirstSubmitQcDate': '2009-09-19', 'lastUpdatePostDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motion amplitude', 'timeFrame': 'Continuously during radiation administration (generally 8 to 15 minutes in duration)', 'description': 'Measured at frequency of 10Hz'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prostate', 'Motion', 'Respiration'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ohsu.edu/radmedicine', 'label': 'Department of Radiation Medicine, Oregon Health and Science University'}]}, 'descriptionModule': {'briefSummary': 'Patient anatomy and position during the course of radiation therapy can vary from those used for treatment planning; a function of patient movement, uncertainty in positioning system, and organ motion. Traditionally, treatment margins are designed to compensate for interfraction prostate setup variability. This approach has the potential to lower the overall effectiveness of treatment because the prostate gland is a continuously moving target whose motion cannot be accurately accounted for solely on the basis of interfraction movement. More recently, the dosimetric relevance of intra-fraction prostate motion has been recognized, and may be compensated for by continuous real-time adaptive radiation therapy afforded by the Calypso 4D Localization System™. In the current study, the investigators propose to characterize intrafraction prostate motion. The investigators hypothesize that intrafraction prostate motion is correlated with respiratory motion.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Localized prostate cancer patients undergoing intensity-modulated radiation therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed stage I-III adenocarcinoma of the prostate gland\n* Age \\> 18 years. Males of all races and ethnic groups\n* Scheduled to receive radiation for definitive therapy\n* Three (3) electromagnetic transponders implanted into prostate gland\n\nExclusion Criteria:\n\n* Does not satisfy inclusion criteria'}, 'identificationModule': {'nctId': 'NCT00980993', 'briefTitle': 'Quantification of Respiratory-induced Prostate Motion', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Pilot Study on the Quantification of Respiratory-induced Prostate Motion During Radiation Therapy Using Continuous Real-time Tracking', 'orgStudyIdInfo': {'id': 'OHSU IRB00005606'}}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'James A. Tanyi, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health and Science University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}