Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)

Study Overview
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Brief Summary
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Present imaging modalities for primary liver cancer (hepatocellular carcinoma or HCC) have several shortcomings. One important shortcoming is the time delay between successful treatment and radiological confirmation of this response. Often it takes several months for anatomical changes to occur and to be appreciated on morphological imaging such as CT or MRI (shrinkage of tumor, absence of contrast enhancement). Functional imaging by means of Fluor-18 deoxyglucose or Fluor-18 Choline (positron emitters, PET-scan) might be an early indicator of response. This early information might help to tailor treatment. For instance, if no response is induced, an early switch in therapy can be planned. The present study investigates whether the routine PET-tracer (Fluor-18 deoxyglucose) and the experimental PET-tracer, Fluor-18 Choline help to predict response if a patient with inoperable primary liver cancer is treated (radionuclide therapy, biologicals).

Official Title
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Role PET Imaging in Response Assessment for Hepatocellular Carcinoma (HCC)

Conditions
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Primary Liver Cancer

Intervention / Treatment
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* Procedure: MRI of the liver before start of treatment
* Procedure: MRI after treatment
* Procedure: PET-scan before treatment start
* Procedure: PET scan after treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria : Male and female are eligible ->18years of age.No upper age limit. not pregnant or breastfeeding capable of understanding the study goals and protocol and to sign the informed consent. Patients are diagnosed with primary liver cancer and referred for treatment with biologicals such as Sorafenib or treatment with radionuclides.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: inoperable liver cancer patients<br> | Procedure: MRI of the liver before start of treatment<br>* MRI of the liver as classic work out of patients (CT-scan if MRI is contra-indicated)<br>Procedure: MRI after treatment<br>* MRI of the liver after 3 - 6 months of treatment (CT-scan if MRI is contra-indicated)<br>Procedure: PET-scan before treatment start<br>* PET-scan with 2 tracers is performed before treatment start<br>Procedure: PET scan after treatment<br>* PET-scan with 2 tracers is repeated 4 weeks following start of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of PET-imaging versus classic response assessment (MRI, CT-scam) in patients with inoperable liver cancer |  | 6 months after start of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary liver cancer