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


Phase 2
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Maria-Angéla M-A CASTILLA-LIEVRE, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hôpital Antoine Béclère 92140 CLAMART-FRANCE

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2010-020221

NCT ID:

NCT01377220

Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular carcinoma
  • Positron Emission Tomography/computed tomography (PET-CT)
  • 11C-Choline
  • alpha fetoprotein
  • Dynamic magnetic resonance imaging
  • Abdomen computed tomography
  • Tumoral liver biopsy
  • Carcinoma
  • Carcinoma, Hepatocellular

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