Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma (CHOLPET)
|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
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|
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Drug: 11C-Choline
11C-Choline : 6MBq/kg on direct intravenous on one minute.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377220
|Contact: Maria-Angéla M-A CASTILLA-LIEVRE, MDemail@example.com|
|CEA-SHFJ||Not yet recruiting|
|Orsay, France, 91400|
|Contact: Maria-Angéla M-A CASTILLA-LIEVRE, MD 01-45-37-48-39 firstname.lastname@example.org|
|Principal Investigator:||Maria-Angéla M-A CASTILLA-LIEVRE, MD||Hôpital Antoine Béclère 92140 CLAMART-FRANCE|