Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01377220
Status:
UNKNOWN
Last Update Posted:
2011-06-21
First Post:
2011-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of 11 C-Choline PET-CT for Detection 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-20', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-06-20', 'lastUpdatePostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'Positron Emission Tomography/computed tomography (PET-CT)', '11C-Choline', 'alpha fetoprotein', 'Dynamic magnetic resonance imaging', 'Abdomen computed tomography', 'Tumoral liver biopsy'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '20956466', 'type': 'BACKGROUND', 'citation': 'Talbot JN, Fartoux L, Balogova S, Nataf V, Kerrou K, Gutman F, Huchet V, Ancel D, Grange JD, Rosmorduc O. Detection of hepatocellular carcinoma with PET/CT: a prospective comparison of 18F-fluorocholine and 18F-FDG in patients with cirrhosis or chronic liver disease. J Nucl Med. 2010 Nov;51(11):1699-706. doi: 10.2967/jnumed.110.075507. Epub 2010 Oct 18.'}, {'pmid': '20069295', 'type': 'BACKGROUND', 'citation': 'Tolvanen T, Yli-Kerttula T, Ujula T, Autio A, Lehikoinen P, Minn H, Roivainen A. Biodistribution and radiation dosimetry of [(11)C]choline: a comparison between rat and human data. Eur J Nucl Med Mol Imaging. 2010 May;37(5):874-83. doi: 10.1007/s00259-009-1346-z. Epub 2010 Jan 13.'}, {'pmid': '18997056', 'type': 'BACKGROUND', 'citation': 'Park JW, Kim JH, Kim SK, Kang KW, Park KW, Choi JI, Lee WJ, Kim CM, Nam BH. A prospective evaluation of 18F-FDG and 11C-acetate PET/CT for detection of primary and metastatic hepatocellular carcinoma. J Nucl Med. 2008 Dec;49(12):1912-21. doi: 10.2967/jnumed.108.055087. Epub 2008 Nov 7.'}, {'pmid': '12571212', 'type': 'BACKGROUND', 'citation': 'Ho CL, Yu SC, Yeung DW. 11C-acetate PET imaging in hepatocellular carcinoma and other liver masses. J Nucl Med. 2003 Feb;44(2):213-21.'}, {'pmid': '19342249', 'type': 'BACKGROUND', 'citation': 'Hwang KH, Choi DJ, Lee SY, Lee MK, Choe W. Evaluation of patients with hepatocellular carcinomas using [(11)C]acetate and [(18)F]FDG PET/CT: A preliminary study. Appl Radiat Isot. 2009 Jul-Aug;67(7-8):1195-8. doi: 10.1016/j.apradiso.2009.02.011. Epub 2009 Feb 20.'}, {'pmid': '16802155', 'type': 'BACKGROUND', 'citation': 'Talbot JN, Gutman F, Fartoux L, Grange JD, Ganne N, Kerrou K, Grahek D, Montravers F, Poupon R, Rosmorduc O. PET/CT in patients with hepatocellular carcinoma using [(18)F]fluorocholine: preliminary comparison with [(18)F]FDG PET/CT. Eur J Nucl Med Mol Imaging. 2006 Nov;33(11):1285-9. doi: 10.1007/s00259-006-0164-9. Epub 2006 Jun 27.'}, {'pmid': '18632827', 'type': 'BACKGROUND', 'citation': 'Yamamoto Y, Nishiyama Y, Kameyama R, Okano K, Kashiwagi H, Deguchi A, Kaji M, Ohkawa M. Detection of hepatocellular carcinoma using 11C-choline PET: comparison with 18F-FDG PET. J Nucl Med. 2008 Aug;49(8):1245-8. doi: 10.2967/jnumed.108.052639. Epub 2008 Jul 16.'}, {'pmid': '19039303', 'type': 'BACKGROUND', 'citation': 'Salem N, Kuang Y, Wang F, Maclennan GT, Lee Z. PET imaging of hepatocellular carcinoma with 2-deoxy-2[18F]fluoro-D-glucose, 6-deoxy-6[18F] fluoro-D-glucose, [1-11C]-acetate and [N-methyl-11C]-choline. Q J Nucl Med Mol Imaging. 2009 Apr;53(2):144-56. Epub 2008 Nov 28.'}, {'pmid': '9189127', 'type': 'BACKGROUND', 'citation': 'Hara T, Kosaka N, Shinoura N, Kondo T. PET imaging of brain tumor with [methyl-11C]choline. J Nucl Med. 1997 Jun;38(6):842-7.'}, {'pmid': '9627331', 'type': 'BACKGROUND', 'citation': 'Hara T, Kosaka N, Kishi H. PET imaging of prostate cancer using carbon-11-choline. J Nucl Med. 1998 Jun;39(6):990-5.'}, {'pmid': '15799049', 'type': 'BACKGROUND', 'citation': 'Li CW, Kuo YC, Chen CY, Kuo YT, Chiu YY, She FO, Liu GC. Quantification of choline compounds in human hepatic tumors by proton MR spectroscopy at 3 T. Magn Reson Med. 2005 Apr;53(4):770-6. doi: 10.1002/mrm.20412.'}, {'pmid': '15918142', 'type': 'BACKGROUND', 'citation': 'Kojiro M, Roskams T. Early hepatocellular carcinoma and dysplastic nodules. Semin Liver Dis. 2005;25(2):133-42. doi: 10.1055/s-2005-871193.'}, {'pmid': '21098794', 'type': 'BACKGROUND', 'citation': 'Kim HO, Kim JS, Shin YM, Ryu JS, Lee YS, Lee SG. Evaluation of metabolic characteristics and viability of lipiodolized hepatocellular carcinomas using 18F-FDG PET/CT. J Nucl Med. 2010 Dec;51(12):1849-56. doi: 10.2967/jnumed.110.079244.'}, {'pmid': '20517911', 'type': 'BACKGROUND', 'citation': 'Kim YK, Lee KW, Cho SY, Han SS, Kim SH, Kim SK, Park SJ. Usefulness 18F-FDG positron emission tomography/computed tomography for detecting recurrence of hepatocellular carcinoma in posttransplant patients. Liver Transpl. 2010 Jun;16(6):767-72. doi: 10.1002/lt.22069.'}, {'pmid': '20480845', 'type': 'BACKGROUND', 'citation': 'Wolfort RM, Papillion PW, Turnage RH, Lillien DL, Ramaswamy MR, Zibari GB. Role of FDG-PET in the evaluation and staging of hepatocellular carcinoma with comparison of tumor size, AFP level, and histologic grade. Int Surg. 2010 Jan-Mar;95(1):67-75.'}, {'pmid': '10845666', 'type': 'BACKGROUND', 'citation': 'Khan MA, Combs CS, Brunt EM, Lowe VJ, Wolverson MK, Solomon H, Collins BT, Di Bisceglie AM. Positron emission tomography scanning in the evaluation of hepatocellular carcinoma. J Hepatol. 2000 May;32(5):792-7. doi: 10.1016/s0168-8278(00)80248-2.'}, {'pmid': '9605913', 'type': 'BACKGROUND', 'citation': 'Delbeke D, Martin WH, Sandler MP, Chapman WC, Wright JK Jr, Pinson CW. Evaluation of benign vs malignant hepatic lesions with positron emission tomography. Arch Surg. 1998 May;133(5):510-5; discussion 515-6. doi: 10.1001/archsurg.133.5.510.'}, {'pmid': '1311035', 'type': 'BACKGROUND', 'citation': 'Okazumi S, Isono K, Enomoto K, Kikuchi T, Ozaki M, Yamamoto H, Hayashi H, Asano T, Ryu M. Evaluation of liver tumors using fluorine-18-fluorodeoxyglucose PET: characterization of tumor and assessment of effect of treatment. J Nucl Med. 1992 Mar;33(3):333-9.'}, {'pmid': '16250051', 'type': 'BACKGROUND', 'citation': 'Bruix J, Sherman M; Practice Guidelines Committee, American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma. Hepatology. 2005 Nov;42(5):1208-36. doi: 10.1002/hep.20933. No abstract available.'}, {'pmid': '11592607', 'type': 'BACKGROUND', 'citation': 'Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodes J; EASL Panel of Experts on HCC. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30. doi: 10.1016/s0168-8278(01)00130-1. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Hepatocellular carcinoma (HCC)is the most frequent primitive tumour of the liver.\n\nRecently, several research studies reported that 11C-choline PET has shown a high detection rate of well differentiated HCC, which is an early stage of primary liver cancer. The aim of this study was to prospectively evaluate the diagnostic accuracy of 11C-choline PET-CT to detect HCC in cirrhotic or non cirrhotic patients.', 'detailedDescription': 'Hepatocellular carcinoma (HCC)is the most frequent primitive tumour of the liver. Although the histological examination remains the reference for the diagnosis, it may be difficult to obtain biopsy material because of difficulty in getting to the lesion or due to their small size. However, it is know that the size of the lesion remains a major prognostic factor, implying the need for an earliest detection, which enhances the chance for curative treatment.PET enables the study of changes in the glucidic or lipidic metabolism of cancer cells. PET-CT, providing both metabolic and anatomic information, improves the performances of this technique. PET with 18F-FDG has not been sensitive enough in the detection of HCC, except in cases of low grade. Recently, several research studies reported that 11C-choline PET has shown a high detection rate of well differentiated HCC, which is an early stage of primary liver cancer.\n\nThe study include 30 patients presenting a suspicion of HCC with or without cirrhosis. Each patient will be examined with two conventional imaging techniques, consisting in dynamic magnetic resonance imaging and computed tomography; alpha fetoprotein measurement will be taken. PET-CT will be acquired after an intravenous injection of 11C-choline. The 11C-choline PET-CT performance for HCC diagnosis will be compare to histological analysis obtained by a tumoral liver biopsy, or by using of the American Association for the study of Liver Disease diagnostic criteria. In absence of the two criteria , the follow up within one year will serve as a reference.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients up to 18 years old with\n* Patients with suspicion hepatocellular carcinoma on conventional imaging(hepatic ultrasonography, abdominal computed tomography, dynamic resonance magnetic)and/or on alpha fetoprotein measurement\n* Patients with suspicion recurrence of hepatocellular carcinoma on conventional imaging(hepatic ultrasonography, abdominal computed tomography, dynamic resonance magnetic)and/or on alpha fetoprotein measurement\n* Patients which perform two conventional imaging techniques, consisting in dynamic magnetic resonance imaging (MRI) and computed tomography (CT)and must have an alpha fetoprotein measurement\n* Patients which perform 18F-FDG PET-CT\n* Informed Consent Form signed and dated by patients\n* Patients which are "Security Social" affiliated\n\nExclusion Criteria:\n\n* Pregnant or suckling women\n* Women able to procreate, without efficient birth control\n* Patients with an other tumoral disease\n* Patients with chemotherapy or surgery from less than four weeks\n* Patients with radiotherapy from less four months'}, 'identificationModule': {'nctId': 'NCT01377220', 'acronym': 'CHOLPET', 'briefTitle': 'Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma', 'organization': {'class': 'OTHER_GOV', 'fullName': "Commissariat A L'energie Atomique"}, 'officialTitle': 'Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': '2010-020221'}}, 'armsInterventionsModule': {'interventions': [{'name': '11C-Choline', 'type': 'DRUG', 'description': '11C-Choline : 6MBq/kg on direct intravenous on one minute.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91400', 'city': 'Orsay', 'country': 'France', 'contacts': [{'name': 'Maria-Angéla M-A CASTILLA-LIEVRE, MD', 'role': 'CONTACT', 'email': 'angele.castilla@abc.aphp.fr', 'phone': '01-45-37-48-39'}], 'facility': 'CEA-SHFJ', 'geoPoint': {'lat': 48.69572, 'lon': 2.18727}}], 'centralContacts': [{'name': 'Maria-Angéla M-A CASTILLA-LIEVRE, MD', 'role': 'CONTACT', 'email': 'angele.castilla@abc.aphp.fr', 'phone': '01-45-37-48-39'}], 'overallOfficials': [{'name': 'Maria-Angéla M-A CASTILLA-LIEVRE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Antoine Béclère 92140 CLAMART-FRANCE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Commissariat A L'energie Atomique", 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'CASTILLA-LIEVRE Maria-Angéla, MD', 'oldOrganization': 'Assistance Publique - Hôpitaux de Paris'}}}}