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

NCT ID: NCT01377220

Last Updated: 2011-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-06-30

Brief 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.

Detailed 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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

11C-Choline

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: collaborator

Commissariat A L'energie Atomique

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assistance Publique - Hôpitaux de Paris

Principal Investigators

Maria-Angéla M-A CASTILLA-LIEVRE, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Antoine Béclère 92140 CLAMART-FRANCE

Locations

CEA-SHFJ

Orsay, , France

Countries

France

Central Contacts

Maria-Angéla M-A CASTILLA-LIEVRE, MD

Role: CONTACT

angele.castilla@abc.aphp.fr

01-45-37-48-39

Facility Contacts

Maria-Angéla M-A CASTILLA-LIEVRE, MD

Role: primary

angele.castilla@abc.aphp.fr

01-45-37-48-39

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Other Identifiers

2010-020221

Identifier Type: -

Identifier Source: org_study_id