Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-09 @ 4:59 AM
Study NCT ID:
NCT03692104
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2018-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US-CT Fusion for Post Implant Dosimetry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-06-22', 'releaseDate': '2021-05-28'}, {'resetDate': '2021-07-15', 'releaseDate': '2021-06-25'}, {'resetDate': '2021-08-20', 'releaseDate': '2021-07-26'}], 'estimatedResultsFirstSubmitDate': '2021-05-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2018-09-27', 'studyFirstSubmitQcDate': '2018-09-28', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of prostate dosimetry assessed by US-CT fusion with respect to the standard MR-CT fusion', 'timeFrame': '1 month', 'description': 'Dosimetry will be calculated using 2 different imaging modalities (US vs MRI) and compared'}], 'secondaryOutcomes': [{'measure': 'Comparison of prostate volume assessed by 2 different imaging modalities', 'timeFrame': '1 month', 'description': 'Assessment of prostate volume as contoured on US vs MRI post implant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'brachytherapy', 'Quality assurance'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Post implant dosimetry is an essential part of quality assurance after permanent seed prostate brachytherapy. CT imaging is the standard of assessment but due to contouring uncertainties, MR-CT fusion is preferred. This is not always available due to financial restrictions. This study explores the possibility of post implant US-CT fusion to improve contouring accuracy and potentially replace the use of MR-CT fusion.', 'detailedDescription': '25 participants undergoing permanent seed prostate brachytherapy will be approached to undergo collection of prostate US images at the completion of their procedure. This will add approximately 5 minutes to the duration of their brachytherapy procedure. The US study will not entail any discomfort or risk to participants as they are still under anesthesia for the implant procedure. The institution standard of care for quality assurance will be complied with, obtaining a CT and MRI of the prostate at 30 days after the procedure. These will be co-registered and analyzed in the normal fashion. In addition, the post implant US images will also be co-registered with the CT and the resulting dosimetric parameters compared.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients undergoing prostate brachytherapy for localized prostate cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* localized prostate cancer suitable for permanent seed implant brachytherapy as either monotherapy or as a boost\n\nExclusion Criteria:\n\n* Unable to undergo MRI'}, 'identificationModule': {'nctId': 'NCT03692104', 'briefTitle': 'US-CT Fusion for Post Implant Dosimetry', 'organization': {'class': 'OTHER', 'fullName': 'British Columbia Cancer Agency'}, 'officialTitle': 'Comparison Between Postoperative Ultrasound-CT Fusion With MRI-CT Fusion for Postimplant Dosimetry for Prostate LDR Permanent Seed Brachytherapy', 'orgStudyIdInfo': {'id': 'H17-02634'}}, 'armsInterventionsModule': {'interventions': [{'name': 'transrectal ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Use of US for post implant quality assessment'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1Y5L3', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}], 'overallOfficials': [{'name': 'Francois Bachand, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'BC Cancer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British Columbia Cancer Agency', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Radiation Oncologist', 'investigatorFullName': 'Juanita Crook', 'investigatorAffiliation': 'British Columbia Cancer Agency'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-05-28', 'type': 'RELEASE'}, {'date': '2021-06-22', 'type': 'RESET'}, {'date': '2021-06-25', 'type': 'RELEASE'}, {'date': '2021-07-15', 'type': 'RESET'}, {'date': '2021-07-26', 'type': 'RELEASE'}, {'date': '2021-08-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Juanita Crook, Radiation Oncologist, British Columbia Cancer Agency'}}}}