Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2025-12-26 @ 2:54 AM
Study NCT ID:
NCT04420702
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2020-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diffusion Basis Spectrum Imaging of the Prostate
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': '-Dr. Kim will be blinded to the DBSI results at the time of biopsy, but will have the conventional MRI interpretation available'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve (AUC) comparison from biopsy and DBSI', 'timeFrame': 'Up to 12 weeks', 'description': '* As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard\n* In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered "clinically significant". The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis.'}, {'measure': 'Receiver operating characteristic (ROC) comparison from biopsy to DBSI', 'timeFrame': 'Up to 12 weeks', 'description': '* As a per patient analysis, the investigators will use the highest Gleason score from the biopsy as the reference standard\n* In the per patient analysis, Gleason 7 or greater, will be the cut-off as this will be considered "clinically significant". The investigators will also perform similar analyses with cut-offs of Gleason 4+3=7 or greater, as well as Gleason 6 or greater. This will serve as the sensitivity analysis.'}, {'measure': 'Prostate sector analysis as measured by comparison of the highest Gleason score from each of the 10 biopsy sectors to the DBSI predicted pathology from each sector', 'timeFrame': 'Up to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Comparison of Gleason score from the MRI regions of interest to the DBSI predicted pathology', 'timeFrame': 'Up to 12 weeks', 'description': '-Only for those patients with a suspicious MRI lesion'}, {'measure': 'Area under the curve (AUC) comparison from DBSI to conventional MRI interpretation', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Receiver operating characteristic (ROC) comparison from DBSI to conventional MRI interpretation', 'timeFrame': 'Up to 12 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Prostate Cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age and willing and able to provide informed consent.\n* Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort")\n* Including those men with:\n\n * an elevated PSA and no prior biopsy\n * an elevated PSA and a negative prior biopsy\n* Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort")\n\nExclusion Criteria:\n\n* Patients with any clinical contraindication to MRI\n\n \\*Including but not limited to:\n * Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators\n * Those with cochlear implants\n * Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate)\n * Those who cannot lie flat for over 1 hour\n* Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)'}, 'identificationModule': {'nctId': 'NCT04420702', 'briefTitle': 'Diffusion Basis Spectrum Imaging of the Prostate', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer', 'orgStudyIdInfo': {'id': '201908215'}, 'secondaryIdInfos': [{'id': 'R01CA258690', 'link': 'https://reporter.nih.gov/quickSearch/R01CA258690', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Detection Cohort (MRI with DBSI)', 'description': '* Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy\n* Standard of care prostate biopsy will be performed within 12 weeks of MRI\n* Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging', 'interventionNames': ['Device: MRI with DBSI analysis']}, {'type': 'EXPERIMENTAL', 'label': 'Active Surveillance Cohort (MRI with DBSI)', 'description': '* Magnetic resonance imaging (MRI) with DBSI analysis prior to prostate biopsy\n* Standard of care prostate biopsy will be performed within 12 weeks of MRI\n* Some participants may go on to receive standard of care radical prostatectomy and those participants may have their prostatectomy specimens scanned via MRI with DBSI imaging', 'interventionNames': ['Device: MRI with DBSI analysis']}], 'interventions': [{'name': 'MRI with DBSI analysis', 'type': 'DEVICE', 'description': "-The procedure will take approximately 1 hour of the participant's time", 'armGroupLabels': ['Active Surveillance Cohort (MRI with DBSI)', 'Early Detection Cohort (MRI with DBSI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joseph Ippolito, M.D.', 'role': 'CONTACT', 'email': 'ippolitoj@wustl.edu', 'phone': '314-362-2928'}, {'name': 'Alex Kim', 'role': 'CONTACT', 'email': 'klima@wustl.edu', 'phone': '314-747-9781'}, {'name': 'Joseph Ippolito, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sheng-Kwei Song, Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael H Johnson, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'centralContacts': [{'name': 'Joseph Ippolito, M.D.', 'role': 'CONTACT', 'email': 'ippolitoj@wustl.edu', 'phone': '314-362-2925'}, {'name': 'Alex Klim', 'role': 'CONTACT', 'email': 'klima@wustl.edu', 'phone': '314-747-9781'}], 'overallOfficials': [{'name': 'Joseph Ippolito, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Cancer Society, Inc.', 'class': 'OTHER'}, {'name': 'The Foundation for Barnes-Jewish Hospital', 'class': 'OTHER'}, {'name': 'Midwest Stone Institute.', 'class': 'OTHER'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}