Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-01 @ 6:40 PM
Study NCT ID:
NCT04219059
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2019-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MR Radiomic Features in Prostate Cancer
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', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2019-12-25', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of surrogate bioimaging markers of histological characteristics in MR images', 'timeFrame': '0-2 years', 'description': 'Segment tumor volumes on the ADC map and extract different imaging features'}], 'secondaryOutcomes': [{'measure': 'Radiomic features from MRI', 'timeFrame': '0-2 years', 'description': 'Evaluate if radiomic features on primitive prostate lesions can describe lymph node involvement.'}, {'measure': 'Extract radiomic features', 'timeFrame': '0-2 years', 'description': 'Evaluate if radiomic features fro MRIon primitive prostate lesions can describe disease extension.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer', 'prostate', 'radiomics', 'MRI', 'prognostic factors'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.', 'detailedDescription': 'Quantitative approaches to medical image analysis have been developed in recent years with the aim to overcome the limitation of qualitative image interpretation, and provide biomarkers for disease characterization. In particular, the new paradigm, "radiomics", is emerging as the high-throughput extraction of quantitative features from imaging which can aid in characterizing phenotype as in vivo expression of tumoral genotype. The goal of radiomics is to extract accurate and reliable quantitative biomarkers which enhance diagnostic confidence in oncology. A combination of correct interpretation of imaging and biopsy has given promising results in terms of detecting clinically significant cancer at radical prostatectomy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '200 male patients who have a pre-intervention prostate MRI with contrast agent from December 2015 to August 30, 2019 and biopsy proven Pca diagnosis, followed by radical prostatectomy will be evaluated.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years of age\n* In house MRI with contrast medium\n* PCa (prostate cancer) biopsy proven diagnosis\n* In house radical prostatectomy\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* MRI without contrast medium\n* Radical prostatectomy executed not in Institution'}, 'identificationModule': {'nctId': 'NCT04219059', 'briefTitle': 'MR Radiomic Features in Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'MR Radiomic Features in Prostate Cancer', 'orgStudyIdInfo': {'id': 'ProTex'}}, 'contactsLocationsModule': {'locations': [{'zip': '20153', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'IBFM-CNR (Istituto di Bioimmagini e Fisiologia Molecolare, National Research Council, Segrate, Italy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Radiology Department', 'investigatorFullName': 'Francesco De Cobelli', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}