Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT05736094
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2023-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound for Detection of Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2023-02-10', 'studyFirstSubmitQcDate': '2023-02-10', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.', 'timeFrame': '1 day', 'description': 'Sensitivity and specificity outcome measures'}, {'measure': 'Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.', 'timeFrame': '1 day', 'description': 'Comparing dual-frequency ultrasound, shear waves ultrasound, CEUS to MRI and histopathological findings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Clinical proof of concept of dual-frequency ultrasound imaging for detection and visualization of prostate cancer.', 'detailedDescription': 'Prospectively recruited patients before prostatectomy and/or definitive radiotherapy will be included in the study. Dual-frequency ultrasound imaging will be compared to standard transrectal ultrasound and MRI. Imaging of primary tumor with dual-frequency ultrasound technology including the use of microbubble contrast-media.\n\nA prostate biopsy and blood sample will be taken from each patient, for histopathology and explorative biomarkers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only men will be included as prostate cancer does not appear in women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years onwards\n* Signed written informed consent to perform rectal and transperineal ultrasound\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT05736094', 'acronym': 'SURF', 'briefTitle': 'Ultrasound for Detection of Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Dual-frequency Ultrasound for Detection of Prostate Cancer', 'orgStudyIdInfo': {'id': '248446'}, 'secondaryIdInfos': [{'id': '313778', 'type': 'OTHER_GRANT', 'domain': 'The Research Council of Norway'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Dual-frequency ultrasound', 'description': 'Dual-frequency ultrasound for detection of prostate cancer', 'interventionNames': ['Device: SURF']}], 'interventions': [{'name': 'SURF', 'type': 'DEVICE', 'description': 'Dual-frequency ultrasound', 'armGroupLabels': ['Dual-frequency ultrasound']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0379', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Wolfgang Lilleby, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, {'name': 'University of Oslo', 'class': 'OTHER'}, {'name': 'The Research Council of Norway', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Wolfgang Lilleby', 'investigatorAffiliation': 'Oslo University Hospital'}}}}