Clinical trial NCT01377220: Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma
Official title: Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Positron Emission Tomography/computed tomography (PET-CT)
11C-Choline
alpha fetoprotein
Dynamic magnetic resonance imaging
Abdomen computed tomography
Tumoral liver biopsy
Lead sponsor: Commissariat A L'energie Atomique
Sponsor class: OTHER_GOV
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2011-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Orsay
country: France
facility: CEA-SHFJ
Study officials:
affiliation: Hôpital Antoine Béclère 92140 CLAMART-FRANCE
name: Maria-Angéla M-A CASTILLA-LIEVRE, MD
role: PRINCIPAL_INVESTIGATOR
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