None listed
Conditions
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
Interventions
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.
Sponsors
Eligibility
Inclusion criteria
Newly diagnosed HCC Barcelona-Clinic Liver Cancer Stage O, A or B Considered for transarterial chemoembolisation, radiofrequency ablation or resection
Exclusion criteria
Pregnancy Previously diagnosed benign or malignant lesions of the liver including HCC