Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT05580835
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2022-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with an imaging diagnosis of hepatocellular carcinoma and candidates to a liver transplant or surgical resection will be submitted to a novel imaging scan, PET / MRI with PSMA. The role of this imaging scan on diagnosis and staging of HCC will be evaluated.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-09-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-11', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic performance of PET MRI - PSMA for HCC', 'timeFrame': '24 months', 'description': 'Patients with a liver lesion diagnosed as hepatocellular carcinoma by MRI or CT and candidates to surgical resection or liver transplant will be submitted to PET MRI with PSMA. Based on the presence or absence of PSMA uptake, sensitivity and specificity of PET MRI for diagnosis of the liver lesion and extrahepatic disease will be calculated.'}, {'measure': 'Degree of PSMA uptake by HCC', 'timeFrame': '24 months', 'description': 'For all liver lesions diagnosed as HCC, the degree of PSMA on PET uptake will be measured and correlated with available pathology information'}], 'secondaryOutcomes': [{'measure': 'Correlation of PSMA uptake and liver nodules histology', 'timeFrame': '24 months', 'description': 'All other non-HCC nodules simultaneously diagnosed will be also evaluated in terms of presence and degree of PSMA uptake. This results will be computed and correlated with all pathology data available'}, {'measure': 'Presence of PSMA uptake on treated liver lesions', 'timeFrame': '24 months', 'description': 'Whenever a treated observation is present, the presence and degree of PSMA uptake will be evaluated and correlated to conventional imaging scans and pathology results available'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positron Emission Tomography/Magnetic Resonance) (PET/MR)', 'Magnetic resonance imaging', 'Hepatocellular carcinoma'], 'conditions': ['Carcinoma, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'Assess the rate and degree of PSMA uptake in patients with hepatocellular carcinoma submitted to PET/MRI scans. The objective is to evaluate its value on diagnosis and staging of HCC.', 'detailedDescription': 'PET/MR - PSMA have emerged as a new method and there are few studies about its role in the evaluation of hepatocellular carcinoma (HCC).\n\nThe hypothesis in this study is that PET/MRI with PSMA might have an additional value in the assessment of hepatocellular carcinoma, contributing to the diagnosis of distant metastasis and to confirm the diagnosis in undetermined nodules by the standard exams (computed tomography and magnetic resonance imaging).\n\nPatients with hepatocellular carcinoma diagnosed by computed tomography or magnetic resonance imaging and referred to a liver transplant or surgery by clinical decision wil be submitted to a whole-body PSMA-PET/MRI and will be included in this prospective unicentric study to be conducted at Instituto do Câncer do Estado de São Paulo (ICESP) and Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP).\n\nAll cases will be evaluated to determine the presence and degree of PSMA uptake on lesions considered as definitely HCCs by CT or MRI. The sensitivity of PSMA - PET/MR for the diagnosis of HCC will be calculated.\n\nThe added value of PSMA - PET MR on systemic staging will be calculated by the number of lesions considered suspicious for malignancy that were not detected by conventional scans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an imaging diagnosis of HCC by a previous CT or MRI, reviewed by an abdominal radiologist\n* Patients candidates to liver transplant or surgical resection\n\nExclusion Criteria:\n\n* Patients with treated liver lesion without viable tumor\n* Age under 18\n* Pregnancy\n* Patients with renal insufficiency;\n* Elevated bilirubin levels (\\>3 mg/dL)\n* Known allergy to contrast media (gadoxetic acid) or radiotracer (PSMA);\n* Blood glucose level higher than 150 mg/dl.\n* MR contraindications (claustrophobia, cardiac pacemakers, neurostimulators, cochlear implants, and insulin pumps).'}, 'identificationModule': {'nctId': 'NCT05580835', 'briefTitle': 'PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Added Value of PET / MR With PSMA for Diagnosis and Staging of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '54382721.3.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PET MRI - PSMA', 'description': 'Patients with an imaging diagnosis of HCC and submitted to PET MRI - PSMA', 'interventionNames': ['Diagnostic Test: PET MRI with PSMA']}], 'interventions': [{'name': 'PET MRI with PSMA', 'type': 'DIAGNOSTIC_TEST', 'description': 'A whole-body PET using PSMA as a radiotracer associated to an upper abdomen MRI with gadoxetic acid as contrast agent', 'armGroupLabels': ['PET MRI - PSMA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246-903', 'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Irai S Oliveira, MD', 'role': 'CONTACT', 'email': 'irai.oliveira@hc.fm.usp.br', 'phone': '5511993662208'}, {'name': 'Sabrina M Ando, MD', 'role': 'CONTACT', 'email': 'sabrina.ando@hc.fm.usp.br', 'phone': '5511974777302'}, {'name': 'Irai S Oliveira, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sabrina M Ando, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Marcelo A Queiroz, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carlos A Buchpiguel, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Irai S Oliveira, MD', 'role': 'CONTACT', 'email': 'irai.oliveira@hc.fm.usp.br', 'phone': '5511993662208'}, {'name': 'Sabrina M Ando, MD', 'role': 'CONTACT', 'email': 'sabrina.ando@hc.fm.usp.br', 'phone': '5511974777302'}], 'overallOfficials': [{'name': 'Irai S Oliveira, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}, {'name': 'Carlos Buchpiguel, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'GE Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Irai Santana de Oliveira', 'investigatorAffiliation': 'University of Sao Paulo'}}}}