Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-30 @ 12:19 PM
Study NCT ID:
NCT05808933
Status:
RECRUITING
Last Update Posted:
2023-04-12
First Post:
2023-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Fingerprinting for Preoperative Evaluation of Lymphovascular Space Invasion in Early Stage Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-29', 'studyFirstSubmitDate': '2023-03-06', 'studyFirstSubmitQcDate': '2023-03-29', 'lastUpdatePostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association between T1-, T2- and ADC-maps and LVSI status', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Correlation between T1-, T2- and ADC-maps and DFS and OS', 'timeFrame': '3 years'}, {'measure': 'Correlation between Radiomics-based analysis and LVSI status and DFS and OS', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this observational prospective study is to investigate the role of Magnetic Resonance Fingerprinting in preoperative assessment of early cervical cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of cervical cancer (FIGO IA-IIA) that will undergo to surgery at Fondazione Policlinico Universitario "A. Gemelli" IRCCS can be included in this study, according to inclusion and exclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with biopsy-proven cervical cancer FIGO stage IA-IIA undergoing surgery;\n* Women aged \\>18 years old;\n* Signed Informed Consent.\n\nExclusion Criteria:\n\n* Concurrent malignancies at other sites;\n* Previous history of neoplasm;\n* Refusal to sign written informed consent'}, 'identificationModule': {'nctId': 'NCT05808933', 'acronym': 'MARF-ESC', 'briefTitle': 'Magnetic Resonance Fingerprinting for Preoperative Evaluation of Lymphovascular Space Invasion in Early Stage Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Magnetic Resonance Fingerprinting for Preoperative Evaluation of Lymphovascular Space Invasion in Early Stage Cervical Cancer', 'orgStudyIdInfo': {'id': '4988'}}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Benedetta B Gui, MD', 'role': 'CONTACT', 'email': 'benedetta.gui@policlinicogemelli.it', 'phone': '0630156054', 'phoneExt': '+39'}, {'name': 'Luca L Russo, MD', 'role': 'CONTACT', 'email': 'luca.russo@guest.policlinicogemelli.it', 'phone': '0630156054', 'phoneExt': '+39'}], 'facility': 'Fondazione Policlinico Universitaro "A. Gemelli" IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Benedetta B Gui, MD', 'role': 'CONTACT', 'email': 'benedetta.gui@policlinicogemelli.it', 'phone': '0630155464', 'phoneExt': '+39'}, {'name': 'Luca L Russo, MD', 'role': 'CONTACT', 'email': 'luca.russo@guest.policlinicogemelli.it', 'phone': '0630156054', 'phoneExt': '+39'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}