To Evaluate the Efficacy and Safety of (18F-FCH) Comparing With (18F-FDG) for Detecting Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase III, Multi-center, Single-blind, Cross-over Study to Evaluate the Efficacy and Safety of 18Ffluorocholine (18F-FCH) Comparing With 18F-fluorodeoxyglucose (18F-FDG) for Detecting Hepatocellular Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02074202
• Other study ID #: 201111019MIB
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 26, 2014
• Last updated: February 27, 2014
• Start date: February 2014
• Est. completion date: March 2015

Study information

• Verified date: February 2014
• Source: National Taiwan University Hospital
• Contact: Kai-Yuan Tzen, MD
• Phone: 886-2-23123456
• Email: tzenky[@]ntuh.gov.tw
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationTaiwan : Food and Drug AdministrationTaiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Liver cancer is a major cause of death among patients of east or southeast asian descent, as well as other population groups, notably in central and west Africa. Diagnosis of liver cancer requires a combination of several imaging techniques and biopsies. Despite this, diagnosis can remain inconclusive or difficult to establish in patients at risk for liver cancer.

The purpose of this multi-center trial is to evaluate novel imaging methods developed to diagnose the most common form of liver cancer, hepatocellular carcinoma. We propose to use novel imaging probes that have been reported to bind to liver cancers but not benign liver lesions that can be confused with liver cancer. Two such imaging probes will be evaluated. 2-[18F]-fluoro-2-deoxy-D-glucose, called [18F]FDG, is a radioactive sugar that is widely used for cancer imaging with a device called positron emission tomography, or PET scans. We already know that [18F]FDG cannot detect some liver cancers that are slow growing. [18F]Fluorocholine ([18F]FCH), another molecule, has been recently reported to be highly effective at detecting liver cancer. In 2010, a French researcher reported 80-90% detection rate by using [18F]FCH alone or in combination with [18F]FDG.

We will compare [18F]FCH and [18F]FDG in evaluating 150 patients over a period of two years. The results will be correlated with those of biopsies and clinical follow-up.

This study will provide valuable data on whether these imaging agents can successfully differentiate malignant liver lesions from benign ones. It will also provide information about whether these imaging agents can successfully assess whether the cancer has spread outside the liver. It will provide data that will allow physicians to determine the optimal imaging protocol to properly diagnose liver cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or female, age = 20 years old.

2. Patient who accepts to enter the study by signing written informed consent.

3. Patient with performance status = 2 Eastern Cooperative Oncology Group (ECOG).

4. Patient with cirrhosis or chronic liver diseases suspected to have at least 1 hepatic nodule larger than 1 cm in diameter detected by conventional image (US, CT, MRI). Patient who has not yet received any therapy relevant to the aforementioned diagnosis. Hepatic nodule is defined as any one of the following conditions: suspicious hepatocellular carcinoma, benign tumor such as hemangioma, adenoma or focal nodular hyperplasia, metastatic lesions from other primary malignancy.

5. Female patient must take reliable contraception method(s) during the participation of the study.

Exclusion Criteria:

1. Patient has serious allergic history or known allergy to 18F-FDG or 18F-FCH.

2. Patient has been diagnosed of multiple malignancies.

3. Female patient who is pregnant, lactating or planning to become pregnant during the study.

4. Patient has been participated in other investigational trials within 28 days prior to study enrollment.

5. Patient is unable to undergo PET/CT scan.

6. Subjects with active systemic infections, or medical conditions that may significantly affect action, adequate uptake and elimination of radiotracer.

7. Subject with conditions judged by the investigator as unsuitable for the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Disease
• Liver Diseases

Intervention

Drug:
• 18F- fluorocholine
To compare the diagnostic efficacy of FCH PET scan to FDG PET scan.
• 18F- fluorodeoxyglucose
To compare the diagnostic efficacy of FCH PET scan to FDG PET scan

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pathological diagnosis of the liver tumor will be compared with the test result of the PET/CT scan findings.	After the study cases finished the two PET/CT scans, the cases will be followed as long as 6 months thereafter. Within this time frame, the study cases will go for a patho-histological diagnosis of the liver tumor. This will be used as the primary outcome.	Within 6 months of follow up after the PET/CT scans.	Yes