Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000194763
Ethics application status
Approved
Date submitted
14/02/2013
Date registered
19/02/2013
Date last updated
19/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
New diagnostic techniques in liver cancer
Scientific title
A pilot study of the utility of combination F18-fluorodeoxyglucose and F18-fluorocholine positron emission tomography imaging in diagnostics, prognosis and treatment response prediction in newly diagnosed hepatocellular carcinoma
Secondary ID [1] 281962 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hepatocellular carcinoma (HCC) 288385 0
Condition category
Condition code
Cancer 288730 288730 0 0
Liver

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1. 18F Fluorodeoxygluose (FDG) Positron Emission Tomography (PET) scan:
This scan is used commonly in many different medical conditions throughout the world and does not differ in technique in this trial when compared to its use in regular clinical practice. A radiotracer (the FDG) will be injected into a peripheral vein, after 60 mins a scan by the PET camera will be performed of the whole body which takes up to 20 mins.

2. 18F Fluorocholine (FCH) Positron Emission Tomography (PET) scan:
This is an experimental scan which has only been used in a small number of trials internationally. It is not in regular clinical use. Its technique is identical to the FDG scan other than the tracer which is FCH and the total imaging time is closer to 30 mins.

3. There will be two groups of patients enrolled, depending upon which standard of care treatment that independant physicians assign:

Arm 1: Both scans performed at the time of diagnosis. These patients will undergo any treatment other than transarterial chemoembolisation.

Arm 2: Both scans performed at the time of diagnosis and then a second set of scans performed after standard of care transarterial chemoembolisation (TACE).

Transarterial chemoembolisation (TACE) is a commonly used treatment modality in HCC worldwide. It is not being assessed in this trial in an experimental fashion. It will only be used in patients who have been enrolled in this trial if the clinical situation demands it. If a patient undergoes TACE, as decided upon by clinicians independant to the trial, a second set of PET scans will be performed 6 weeks after in order to assess the treatment response. TACE will be performed as standard of care which includes femoral arterial access, angiography to locate the HCC feeding vessels, then embolisation of the vessels with beads loaded with epirubicin (the chemotherapy agent). Depending upon the clinical situation, patients may undergo several TACE procedures over months to years. However, only one set of PET scans will performed after the first TACE.


The two arms exist as we are using the PET scans in different ways. In the first arm, patients simply undergo the two PET scan at time of diagnosis which completes their involvement. In the second arm, patients have the PET scans at time of enrollment, they then undergo TACE, then 6 weeks later have another set of PET scans. The results will not be compared against each other or against any other groups undergoing any other intervention of test.
All patients will be followed for 24 months after enrollment.
Intervention code [1] 286529 0
Not applicable
Comparator / control treatment
There is no control arm.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288874 0
1: sensitivity and specificity of combined FCH and FDG PET scans for diagnosing HCC
Timepoint [1] 288874 0
At the time of diagnosis
Secondary outcome [1] 301214 0
1: accuracy of predicting degree of differentiation and presence of microvascular invasion in newly diagnosed HCC using combined FDG and FCH PET scans
Timepoint [1] 301214 0
At time of diagnosis
Secondary outcome [2] 301215 0
2: accuracy of predicting time to progression and overall survival in newly diagnosed HCC using combined FDG and FCH PET scans
Timepoint [2] 301215 0
Death
Secondary outcome [3] 301216 0
3: accuracy of predicting treatment response, disease progression and disease recurrence after transarterial chemoembolisation for newly diagnosed HCC using combined FDG and FCH PET scans
Timepoint [3] 301216 0
6 weeks after transarterial chemoembolisation

Eligibility
Key inclusion criteria
Newly diagnosed HCC
Barcelona-Clinic Liver Cancer Stage O, A or B
Considered for transarterial chemoembolisation, radiofrequency ablation or resection
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
Previously diagnosed benign or malignant lesions of the liver including HCC

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 286739 0
Hospital
Name [1] 286739 0
Department of Nuclear Medicine
Country [1] 286739 0
Australia
Primary sponsor type
Hospital
Name
Department of Nuclear Medicine
Address
Sir Charles Gairdner Hospital
Hospital Ave,
Nedlands,
Perth, WA
6009
Country
Australia
Secondary sponsor category [1] 285517 0
None
Name [1] 285517 0
Address [1] 285517 0
Country [1] 285517 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288813 0
Sir Charles Gairdner Hospital HREC
Ethics committee address [1] 288813 0
Sir Charles Gairdner Hospital,
Hospital Ave,
Nedlands,
Perth, WA
6009
Ethics committee country [1] 288813 0
Australia
Date submitted for ethics approval [1] 288813 0
01/10/2012
Approval date [1] 288813 0
14/12/2012
Ethics approval number [1] 288813 0
2012-155

Summary
Brief summary
Cancer of the liver is becoming more common in Australia. A PET scan is used to diagnose many forms of cancer, but it is not commonly used in cancer of the liver. This study aims to determine whether a PET scan is an accurate way of diagnosing cancers of the liver by performing this scan on someone who we know already has a cancer of the liver. We will also see if a PET scan can provide other pieces of information about the liver cancer that we do not already have. Finally, we will investigate whether a second PET scan done after a certain type of treatment for the liver cancer will tell us whether that cancer has responded to the treatment. If the results from the research project are encouraging, we will begin larger trials. Hopefully in the future, PET scans in liver cancer will become an important part of management and will improve the outcomes for patients with this disease. Who is it for? You may be eligible to join this study if you are aged 18 to 90 years old, with newly diagnosed Hepatocellular Carcinoma (HCC), Barcelona-Clinic Liver Cancer Stage O, A or B, and considered for transarterial chemoembolisation, radiofrequency ablation or resection Trial details In this study, you will receive an 18F Fluorodeoxygluose (FDG) Positron Emission Tomography (PET) scan, as well as an 18F Fluorocholine (FCH) Positron Emission Tomography (PET). One group of participants will receive both scans performed at the time of diagnosis, and a second group will receive both scans performed at the time of diagnosis followed by a second set of scans performed after standard care transarterial chemoembolisation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37890 0
Dr Michael Wallace
Address 37890 0
Department of Hepatology
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands
Perth, WA
6009
Country 37890 0
Australia
Phone 37890 0
+61 8 93463333
Fax 37890 0
Email 37890 0
[email protected]
Contact person for public queries
Name 37891 0
Dr Michael Wallace
Address 37891 0
Department of Hepatology
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands
Perth, WA
6009
Country 37891 0
Australia
Phone 37891 0
+61 8 93463333
Fax 37891 0
Email 37891 0
[email protected]
Contact person for scientific queries
Name 37892 0
Dr Michael Wallace
Address 37892 0
Department of Hepatology
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands
Perth, WA
6009
Country 37892 0
Australia
Phone 37892 0
+61 8 93463333
Fax 37892 0
Email 37892 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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