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

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
11C-Choline
Sponsored by
Commissariat A L'energie Atomique
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Positron Emission Tomography/computed tomography (PET-CT), 11C-Choline, alpha fetoprotein, Dynamic magnetic resonance imaging, Abdomen computed tomography, Tumoral liver biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CEA-SHFJ

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 7, 2011
Last Updated
June 20, 2011
Sponsor
Commissariat A L'energie Atomique
Collaborators
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01377220
Brief Title
Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma
Acronym
CHOLPET
Official Title
Evaluation of 11 C-Choline PET-CT for Detection of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Commissariat A L'energie Atomique
Collaborators
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
11C-Choline
Intervention Description
11C-Choline : 6MBq/kg on direct intravenous on one minute.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria-Angéla M-A CASTILLA-LIEVRE, MD
Phone
01-45-37-48-39
Email
angele.castilla@abc.aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria-Angéla M-A CASTILLA-LIEVRE, MD
Organizational Affiliation
Hôpital Antoine Béclère 92140 CLAMART-FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CEA-SHFJ
City
Orsay
ZIP/Postal Code
91400
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria-Angéla M-A CASTILLA-LIEVRE, MD
Phone
01-45-37-48-39
Email
angele.castilla@abc.aphp.fr

12. IPD Sharing Statement

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

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