Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02936856
Status:
UNKNOWN
Last Update Posted:
2017-02-24
First Post:
2016-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatic Arteriography in Liver Cancer Diagnosis and Staging Applications
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'lastUpdateSubmitDate': '2017-02-23', 'studyFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2016-10-14', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of numbers of confirmatory diagnosis of malignant lesions before and after hepatic arteriography', 'timeFrame': '1 year', 'description': 'Comparing the numbers and distribution of confirmatory diagnosis (positive/negative) of malignant lesions before and after hepatic arteriography, which to re-evaluate the staging of primary liver cancer and to further provide better therapeutic strategies'}], 'secondaryOutcomes': [{'measure': 'Detection of distribution of confirmatory diagnosis of malignant lesions before and after hepatic arteriography', 'timeFrame': '1 year', 'description': 'Comparing the distribution of confirmatory diagnosis (positive/negative) of malignant lesions before and after hepatic arteriography, which to re-evaluate the staging of primary liver cancer and to further provide better therapeutic strategies'}]}, 'conditionsModule': {'conditions': ['HepatoCellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'Primary liver cancer is one of the most common malignant tumor and leading cause of cancer-related death worldwide. Basically therapeutic strategies were considered and given based on the staging of liver cancer. Thus, the confirmatory diagnosis of numbers and distribution of malignant lesions were extreme important. Enhanced CT or MRI is routinely imaging scans to detect and identify lesions. Unfortunately, some malignant lesions usually presented untypical imaging characteristics, especially among lesions no larger than 1 cm, which misleading to the exact staging of liver cancer and the optimal therapeutic strategies.\n\nBasically most of blood supply for malignant liver tumors is from the hepatic artery. Based on this fact, hepatic arterial digital subtraction angiography could potentially elevate the accuracy and sensitivity of detection malignant lesions numbers and distribution.\n\nIn this study the investigators will compare the numbers and distribution of malignant lesions before and after hepatic arteriography, then to revise the staging of liver cancer and to provide better therapeutic strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary liver cancer who is firstly diagnosed in Affiliated Tumor Hospital of Guangxi Medical University after November 2015, and the clinical diagnostic criteria is according to China\'s "primary liver cancer diagnostic and treatment practices (2011)". Clinical diagnostic criteria: In all solid tumors, there is only hepatocellular carcinoma can use clinical diagnostic criteria, which is recognized by domestic and foreign countries. Combined with China\'s national conditions, history of the national standards and clinical practice, the Expert Group can establish the clinical diagnosis of hepatocellular carcinoma requested the following conditions 1 + 2a or 1 + 2b + 3 at the same time satisfy:\n\n * Patients have evidence of liver cirrhosis or HBV and / or HCV infection (HBV and / or HCV antigen positive).\n * Typical imaging features of hepatocellular carcinoma: liver lesion shows arterial hypervascularity and venous or delayed phase washout in multidetector CT scan and / or dynamic contrast enhanced MRI. a: If the liver lesion diameter≥2cm, the diagnosis of hepatocellular carcinoma can be made when typical imaging features show in one of the imaging methods. b: If the liver lesion diameter is between 1 to 2cm, the diagnosis of hepatocellular carcinoma can be made when typical imaging features show in both of the imaging methods.\n * Serum AFP≥400μg/L for 1 month or ≥200μg/L for 2 month, and can rule out other causes of AFP increasing (pregnancy, reproductive system embryo-derived tumors, active liver disease and secondary liver cancer, etc.).\n\nExclusion Criteria:\n\n* Patients do not conform to China\'s "primary liver cancer diagnostic and treatment practices (2011)".\n* Patients allergic to Iodine-containing contrast agents or with obvious hyperthyroidism.\n* Patients with severe cardiovascular disease or liver or renal insufficiency, who do not tolerate digital subtraction angiography or will significantly increase the risk of diseases.\n* Patients have severe coagulation disorders or are extreme weak.\n* Patients have fever or have infection on the puncture site.\n* Patients suffer from mental illness or cannot cooperate with the treatment.'}, 'identificationModule': {'nctId': 'NCT02936856', 'acronym': 'RDSA', 'briefTitle': 'Hepatic Arteriography in Liver Cancer Diagnosis and Staging Applications', 'organization': {'class': 'OTHER', 'fullName': 'Guangxi Medical University'}, 'orgStudyIdInfo': {'id': 'GuangxiMUBT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'After Hepatic Arteriography', 'interventionNames': ['Device: Hepatic Arteriography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Before Hepatic Arteriography', 'interventionNames': ['Device: Hepatic Arteriography']}], 'interventions': [{'name': 'Hepatic Arteriography', 'type': 'DEVICE', 'armGroupLabels': ['After Hepatic Arteriography', 'Before Hepatic Arteriography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '530000', 'city': 'Nanning', 'state': 'Guangxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bai Tao, MD', 'role': 'CONTACT', 'email': '25859373@qq.com', 'phone': '+86 13878862632'}], 'facility': 'TaoBai', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangxi Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'TaoBai', 'investigatorAffiliation': 'Guangxi Medical University'}}}}