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

Commissariat A L'energie Atomique

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: 11C-Choline

Study type: Interventional

Funder types: Other

Identifiers

NCT01377220

2010-020221

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)