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

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ClinicalTrials.gov Identifier: NCT01377220
Recruitment Status : Unknown
Verified January 2011 by Commissariat A L'energie Atomique.
Recruitment status was:  Not yet recruiting
First Posted : June 21, 2011
Last Update Posted : June 21, 2011
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
Commissariat A L'energie Atomique

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.


Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: 11C-Choline Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma
Study Start Date : June 2011
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377220


Contacts
Contact: Maria-Angéla M-A CASTILLA-LIEVRE, MD 01-45-37-48-39 angele.castilla@abc.aphp.fr

Locations
France
CEA-SHFJ Not yet recruiting
Orsay, France, 91400
Contact: Maria-Angéla M-A CASTILLA-LIEVRE, MD    01-45-37-48-39    angele.castilla@abc.aphp.fr   
Sponsors and Collaborators
Commissariat A L'energie Atomique
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Maria-Angéla M-A CASTILLA-LIEVRE, MD Hôpital Antoine Béclère 92140 CLAMART-FRANCE

Publications:

Responsible Party: CASTILLA-LIEVRE Maria-Angéla, MD, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01377220     History of Changes
Other Study ID Numbers: 2010-020221
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: June 21, 2011
Last Verified: January 2011

Keywords provided by Commissariat A L'energie Atomique:
Hepatocellular carcinoma
Positron Emission Tomography/computed tomography (PET-CT)
11C-Choline
alpha fetoprotein
Dynamic magnetic resonance imaging
Abdomen computed tomography
Tumoral liver biopsy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents