Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-30 @ 9:30 AM
Study NCT ID:
NCT00081094
Status:
COMPLETED
Last Update Posted:
2013-04-23
First Post:
2004-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography Using Carbon-11 Acetate and Fludeoxyglucose F 18 in Detecting Hepatocellular Carcinoma (Liver Cancer) in Patients With Known or Suspected Liver Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-22', 'studyFirstSubmitDate': '2004-04-07', 'studyFirstSubmitQcDate': '2004-04-07', 'lastUpdatePostDateStruct': {'date': '2013-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18'}], 'secondaryOutcomes': [{'measure': 'Determine whether PET identifies additional sites of disease not detected by conventional imaging'}, {'measure': 'Obtain a preliminary estimate of the impact of PET on management of patients with HCC.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adult primary hepatocellular carcinoma', 'recurrent adult primary liver cancer', 'localized resectable adult primary liver cancer'], 'conditions': ['Liver Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Imaging procedures, such as carbon-11 acetate positron emission tomography (PET) and fludeoxyglucose F 18 PET, may improve the ability to detect hepatocellular carcinoma (liver cancer) and allow doctors to plan the most effective treatment.\n\nPURPOSE: This clinical trial is studying how well carbon-11 acetate PET and fludeoxyglucose F 18 PET work in detecting cancer in patients with liver cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION:\n\n* Biopsy-proved HCC (stage I and II by conventional staging) or one or more of the following in a patient with clinically documented cirrhosis:\n* AFP \\> 200 mg/dL;\n* A contrast-enhancing tumor mass (\\>1 cm) by CT or MRI; or\n* A tumor mass confirmed by arteriography.\n* Patient must provide written informed consent and have completed conventional imaging and staging before initiation of PET imaging.\n\nEXCLUSION:\n\n* Pediatric patients under the age of 18 will be excluded from consideration from this study.\n* Patients with a known prior malignancy (with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years will be excluded from entry into the study. However, patients with a prior HCC thought to have a new primary or recurrent HCC are eligible.\n* Pregnant and breastfeeding patients.\n* Patients with poorly controlled diabetes mellitus (fasting blood glucose level \\> 200 mg/dL)'}, 'identificationModule': {'nctId': 'NCT00081094', 'briefTitle': 'Positron Emission Tomography Using Carbon-11 Acetate and Fludeoxyglucose F 18 in Detecting Hepatocellular Carcinoma (Liver Cancer) in Patients With Known or Suspected Liver Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Detection of Hepatocellular Carcinoma by Positron Emission Tomography With C-Acetate-11 and F-fluorodeoxyglucose-18', 'orgStudyIdInfo': {'id': 'CDR0000358907'}, 'secondaryIdInfos': [{'id': 'P30CA091842', 'link': 'https://reporter.nih.gov/quickSearch/P30CA091842', 'type': 'NIH'}, {'id': 'WU-03-0771'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PET scan (FDG-PET & 11C-acetate-PET)', 'description': 'Patients will undergo routine clinical FDG-PET and research 11C-acetate-PET prior to planned surgical resection of the lesion(s) or explantation of the liver.', 'interventionNames': ['Procedure: 18F-Fluorodeoxyglucose-PET (FDG-PET)', 'Procedure: 11Carbon-Acetate-PET']}], 'interventions': [{'name': '18F-Fluorodeoxyglucose-PET (FDG-PET)', 'type': 'PROCEDURE', 'armGroupLabels': ['PET scan (FDG-PET & 11C-acetate-PET)']}, {'name': '11Carbon-Acetate-PET', 'type': 'PROCEDURE', 'armGroupLabels': ['PET scan (FDG-PET & 11C-acetate-PET)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'William C. Chapman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}