Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— CHOLPET  

Official title:

Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01377220
• Other study ID #: 2010-020221
• Status: Not yet recruiting
• Phase: Phase 2
• First received: June 7, 2011
• Last updated: June 20, 2011
• Start date: June 2011
• Est. completion date: June 2014

Study information

• Verified date: January 2011
• Source: Commissariat A L'energie Atomique
• Contact: Maria-Angéla M-A CASTILLA-LIEVRE, MD
• Phone: 01-45-37-48-39
• Email: angele.castilla[@]abc.aphp.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Hepatocellular carcinoma (HCC)is the most frequent primitive tumour of the liver.

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. 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.

Description:

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.

The 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients up to 18 years old with

• Patients with suspicion hepatocellular carcinoma on conventional imaging(hepatic ultrasonography, abdominal computed tomography, dynamic resonance magnetic)and/or on alpha fetoprotein measurement

• Patients with suspicion recurrence of hepatocellular carcinoma on conventional imaging(hepatic ultrasonography, abdominal computed tomography, dynamic resonance magnetic)and/or on alpha fetoprotein measurement

• 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

• Patients which perform 18F-FDG PET-CT

• Informed Consent Form signed and dated by patients

• Patients which are "Security Social" affiliated

Exclusion Criteria:

• Pregnant or suckling women

• Women able to procreate, without efficient birth control

• Patients with an other tumoral disease

• Patients with chemotherapy or surgery from less than four weeks

• Patients with radiotherapy from less four months

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• 11C-Choline
11C-Choline : 6MBq/kg on direct intravenous on one minute.

Locations

Country	Name	City	State
France	CEA-SHFJ	Orsay

Sponsors (2)

Lead Sponsor	Collaborator
Commissariat A L'energie Atomique	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (20)

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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. — View 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. — View 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. — View 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. Epub 2006 Jun 27. — View 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. — View 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. — View 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. — View Citation

* Note: There are 20 references in all — Click here to view all references