Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-19 @ 12:30 AM
Study NCT ID:
NCT01810627
Status:
COMPLETED
Last Update Posted:
2017-09-26
First Post:
2013-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Application of Megavoltage Imaging to Reduce Artifact After Seed Implants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-22', 'studyFirstSubmitDate': '2013-03-11', 'studyFirstSubmitQcDate': '2013-03-11', 'lastUpdatePostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in prostate volume measured in cm^3', 'timeFrame': 'One month post implant', 'description': 'Change in prostate volume measured with trans-rectal ultrasound at baseline versus prostate volume measured with KVCT and MVCT.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prostate', 'Cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a non-randomized study to evaluate the utility of MVCT as a quality assurance measure in patients treated with interstitial permanent seed implants for low and intermediate risk prostate cancer. All patients will received the same standard of care treatment but will receive an additinoal CT image of the prostate.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale 50-80 years of age Eligible for interstitial brachytherapy implants\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01810627', 'briefTitle': 'Application of Megavoltage Imaging to Reduce Artifact After Seed Implants', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Application of Megavoltage Imaging to Reduce Artifact Following Interstitial Seed Implants for Prostate Adenocarcinoma', 'orgStudyIdInfo': {'id': '13-RAD-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MVCT', 'description': 'Patients will receive an additional MVCT scan at their one month follow up visit.', 'interventionNames': ['Radiation: MVCT']}], 'interventions': [{'name': 'MVCT', 'type': 'RADIATION', 'description': 'Patients will receive an additional MVCT scan at their one month follow up visit.', 'armGroupLabels': ['MVCT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Markey Cancer Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'William St. Clair, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lucille P. Markey Cancer Center at University of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'William St Clair', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Faculty, Radiation Medicine', 'investigatorFullName': 'William St Clair', 'investigatorAffiliation': 'University of Kentucky'}}}}