se of the PET/CT [18F]-Fluorocholine: Diagnostics and Follow-up of Hepatocellular Carcinoma
- Conditions
- hepatocellular carcinomalivercancer1001981510019818
- Registration Number
- NL-OMON36749
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
1. 18 years of age or older
2. Signed informed consent
3. Affirmed or suspected diagnosis of HCC based on current standard of care and guidelines
4. Expected (partial) treatment and follow-up at the AMC
Exclusioncriteria in regard to the multiphase CT scan combined with the PETscan include:
1.1. Renal impairment and allergy to the contrast agent. These patients undergo pre-treatment according to the AMC radiology protocol, after which the combined FCH PET / (multiphase) CT scan will be performed.
1.2. If patients cannot undergo the multiphase CT scan, an MRI is performed instead and FCH PET/CT is made with a low dose CT scan and no contrast is used.
1.3. If however no imaging studies with CT or MR are possible, because of contraindications against both imaging modalities, patient is excluded.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>For further details see - Protocol section: 2 -<br /><br><br /><br>1. Sensitivity and specificity of the FCH PET/CT scan<br /><br><br /><br><br /><br>( in reference to current golden standard of: )<br /><br>- Histological outcome (and differentiation of the tumor)<br /><br><br /><br>OR:<br /><br><br /><br>- Outcome of imaging results corresponding with HCC</p><br>
- Secondary Outcome Measures
Name Time Method <p>For further details see - Protocol section: 2 -<br /><br><br /><br>1. Diagnosis of HCC, spread of the disease or metastatic disease in an earlier<br /><br>stage, compared to diagnosis with conventional imaging modalities.<br /><br><br /><br>2. Change in treatment<br /><br><br /><br>3. Differentiation grade of the HCC based on the SUV-ratio (golden standard is<br /><br>histological outcome)</p><br>