Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT05761912
Status:
UNKNOWN
Last Update Posted:
2023-03-09
First Post:
2022-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2022-12-18', 'studyFirstSubmitQcDate': '2023-02-27', 'lastUpdatePostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive rate of ultrasound radiomics fusion targeted biopsy', 'timeFrame': 'Up to seventh day when the pathological results were obtained after the targeted biopsy', 'description': 'Positive rate of ultrasound radiomics fusion targeted biopsy'}, {'measure': 'Positive rate of mpMRI cognitive fusion targeted biopsy', 'timeFrame': 'Up to seventh day when the pathological results were obtained after the targeted biopsy', 'description': 'Positive rate of mpMRI cognitive fusion targeted biopsy'}, {'measure': 'Ultrasound radiomics parameters', 'timeFrame': 'The 30min following the transrectal ultrasonography', 'description': 'The ultrasound images are obtained by transrectal ultrasound while prostate biopsy. Then investigators use 3D-Slicer software to draw the area of interest (ROI). "Pyradiomics" library will be used to extract the radiomics features.'}], 'secondaryOutcomes': [{'measure': "Gleason's score of positive tissue", 'timeFrame': 'Up to seventh day when the pathological results were obtained after the targeted biopsy', 'description': "Gleason's score of positive tissue from targeted prostate biopsy. Prostate cancer was graded by Gleason score (GS) ranging from 6 to 10. Tumors of GS 6 (3 + 3) are considered low grade (LG), while GS ≥7 are high grade (HG)."}, {'measure': 'PI-RADS score', 'timeFrame': 'Within one month prior to prostate biopsy.', 'description': 'Prostate Imaging Reporting and Data System (PI-RADS) score was obtained according to multiparametric magnetic resonance imaging. PI-RADS is used to standardize interpretation of prostate MRI. Each lesion is assigned a score from 1 to 5 indicating the likelihood of clinically significant cancer. PI-RADS 1: clinically significant cancer is highly unlikely to be present; PI-RADS 2: clinically significant cancer is unlikely to be present; PI-RADS 3: the presence of clinically significant cancer is equivocal; PI-RADS 4: clinically significant cancer is likely to be present; PI-RADS 5: clinically significant cancer is highly likely to be present.'}, {'measure': 'tPSA and fPSA', 'timeFrame': 'Within one month prior to prostate biopsy.', 'description': 'tPSA means total Prostate-Specific Antigen (PSA), and fPSA means free Prostate-Specific Antigen. If the tPSA results are in the borderline range (4 to 10), fPSA can be useful in helping distinguish between prostate cancer or benign prostatic hyperplasia (BPH).'}, {'measure': 'Prostate tumor capsular invasion and positive surgical margin', 'timeFrame': 'Up to seventh day after radical prostatectomy.', 'description': 'The pathological specimens of the surgically resected prostate were used to determine whether there were capsular invasion or positive surgical margins. In the pathological sections, tumor cells could be identified by staining and microscopic observation at the tissue cauterization margin and capsule, and then capsular invasion or positive surgical margins could be identified.'}, {'measure': 'Incidence of complications', 'timeFrame': 'Up to the first month after the targeted biopsy', 'description': 'Incidence of complications associated with prostate biopsy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer', 'Ultrasound', 'Radiomics']}, 'descriptionModule': {'briefSummary': 'To predict prostate cancer and its prognosis by ultrasound radiomics in ultrasound fusion prostate targeted biopsy.', 'detailedDescription': 'Investigators plan to develop a diagnostic and prognostic evaluation model for prostate cancer according to analyze the abnormal echo of prostate ultrasound images by radiomics. The model was used to perform ultrasound radiomics fusion prostate biopsy, and the accuracy was compared with that of MRI cognitive fusion biopsy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged above 55 who had an indication for prostate biopsy will be screened for eligibility.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥55 years old.\n2. Patients had multiparametric magnetic resonance imaging (mpMRI) data within 3 months before biopsy and tPSA/fPSA within 1 month before biopsy.\n3. Patients had any of the following indications for prostate biopsy:\n\n * Suspicious prostate nodules were found by digital rectal examination\n * Suspicious lesions were detected by B-ultrasound or MRI\n * PSA\\>10ng/ml\n * PSA 4-10ng/ml, with abnormal f/tPSA and/or PSAD values\n\nExclusion Criteria:\n\n1. malignant tumors other than prostate adenocarcinoma indicated by pathology.\n2. Combined with other malignant tumors (such as rectal cancer, bladder cancer, testicular cancer, etc.) that may affect the imaging findings of transrectal ultrasound or mpMRI.\n3. Other conditions that would preclude needle biopsy: cachexia, decompensation of organ function, hemorrhagic diseases, local infection, etc'}, 'identificationModule': {'nctId': 'NCT05761912', 'briefTitle': 'Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Minhang Central Hospital'}, 'officialTitle': 'Application of Ultrasound Radiomics in Ultrasound Fusion Targeted Prostate Biopsy', 'orgStudyIdInfo': {'id': 'Prostate Radiomics-1027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ultrasound fusion targeted biopsy', 'description': 'Prostate ultrasound had abnormal echo and radiomics analysis showed high scores'}, {'label': 'mpMRI cognitive fusion targeted biopsy', 'description': 'PI-RADS score ≥ 3'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chang He', 'role': 'CONTACT', 'email': 'zsyhuangjq@163.com', 'phone': '13818794604'}], 'overallOfficials': [{'name': 'Jiaqi Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minhang Hospital, Fudan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Minhang Central Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Clinical Professor', 'investigatorFullName': 'Chang He', 'investigatorAffiliation': 'Shanghai Minhang Central Hospital'}}}}