Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 4:42 PM
Study NCT ID:
NCT05950503
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2023-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of MRI in the Evaluation of Hepatic Metastases of Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-25', 'studyFirstSubmitDate': '2023-07-10', 'studyFirstSubmitQcDate': '2023-07-10', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgery conversion rates', 'timeFrame': '3 years', 'description': 'Negative conversion rate is: patients initially considered operable and subsequently not considered suitable for surgery compared to the total number of patients enrolled.\n\nPositive conversion rate is: patients initially deemed ineligible for surgery and subsequently operated, compared to the total number of patients enrolled.'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'Time from enrollment to death'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This study wants to evaluate the use of MRI in the managemente of mCRC with liver only metastases.', 'detailedDescription': 'This study wants to evaluate the use of MRI in the managemente of mCRC with liver only metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Colorectal cancer patients with liver metastases treated at the U.O.C. of Medical Oncology of Foundation Agostino Gemelli University Hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years;\n* Histological diagnosis of colorectal cancer;\n* Presence of liver metastases in the staging exams (chest-abdomen CT with contrast medium or PET-CT with 18-FDG);\n* At least one measurable liver lesion according to RECIST 1.1 criteria;\n* Adequate organ and marrow function.\n\nExclusion Criteria:\n\n* Age \\< 18 years;\n* Inability to undergo MRI;\n* Major contraindications to liver surgery;\n* No written informed consent.'}, 'identificationModule': {'nctId': 'NCT05950503', 'acronym': 'RMN-CRC', 'briefTitle': 'Role of MRI in the Evaluation of Hepatic Metastases of Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Single-center Ambispective Observational Study on the Role of Magnetic Resonance Imaging (MRI) in the Evaluation of Patient Affected by Hepatic Metastases of Carcinoma of the', 'orgStudyIdInfo': {'id': '5829'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mCRC patients', 'description': 'Patients with mCRC with liver-only metastases', 'interventionNames': ['Radiation: Hepatic MRI']}], 'interventions': [{'name': 'Hepatic MRI', 'type': 'RADIATION', 'description': 'The patients will undergo hepatic MRI in pre-established timepoints', 'armGroupLabels': ['mCRC patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lisa Salvatore, MD, PhD', 'role': 'CONTACT', 'email': 'lisa.salvatore@policlinicogemelli.it', 'phone': '0630156318'}], 'facility': 'Policlinico Agostino Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': 'Lisa Salvatore, MD, PhD', 'role': 'CONTACT', 'email': 'lisa.salvatore@policlinicogemelli.it', 'phone': '0630156318'}], 'overallOfficials': [{'name': 'Lisa Salvatore, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}