Use of the PET/CT [18F]-Fluorocholine: Diagnostics and Follow-up of Hepatocellular Carcinoma

For further details see - Protocol section: 1 -

With this study we want to ease the challenge of non-invasive diagnosis and
follow-up of hepatocellular carcinomas: We hope to correctly, and in an early
stage, assess the diagnosis, recurrence and disease progression of HCC to
ultimately optimize patient*s treatment and follow-up.

The AASLD has established a set of criteria for diagnosing HCC. The current
guidelines recommend radiological imaging (MRI and CT). When 2 imaging
modalitities show a hypervascular lesion in arterial phase, with signs of
(rapid) wash-out, an HCC is most likely. Small HCC (< 20mm) are difficult to
diagnose with non-invasive techniques alone, especially in the cirrhotic liver.
When diagnosis remains uncertain, histological affirmation is recommended.
During follow-up of HCC imaging results are complicated by the often
intervening effects of treatment, including necrosis, local inflammation and
fibrosis.The disappointing sensitivity of the imaging modalities calls for an
accurate non-invasive diagnostic tool.

[F18] fluorocholine (FCH) PET/CT
With the use of Positron Emission Tomography (PET) the metabolism of a specific
compound within an organ or tumor can be assessed, when labeled with a
radioactive tracer. The diagnostic accuracy of the conventional glucose PET/CT
scan (FDG PET) however, is disappointing, especially in well differentiated
HCC. In *a proof of concept* study by Talbot et al, the FDG PET/CT showed a
sensitivity of only 56%, compared to a 100% sensitivity of the FCH PET in
lesions larger then 9mm. They concluded that FCH is potentially useful in the
initial detection of HCC or in the detection of recurrent disease. Furthermore,
study suggests that differentiation between vital and non-vital tumor tissue
can be made using the FCH tracer. Altogether, the PET/CT FCH is a promising
diagnostic additive and possibly employable in the follow-up of HCC after
resection, local ablation, TACE and drug treatment to assess treatment
effectiveness, recurrence and metastatic disease.

Hypothesis
Accurate assessment of diagnosis, recurrence, disease progression or metastases
of hepatocellular carcinoma is possible using the 18F-fluorocholine PET/CTscan.

For further details see - Protocol section: 2 -

Aim
o Assessment of the accuracy of the FCH PET/CT scan in diagnosing HCC.

o Assesment of radical surgical resection, using the FCH PET/CTscan.
o Assesment of recurrence after surgical resection, using the FCH PET/CTscan.

o Assesment of treatment response (to RFA, TACE and Sorafenib) in palliative
patient care, using the FCH PET/CTscan.


o Predicting grade of differentiation of HCC (strongly
correlated with prognosis) using the FCH PET/CT

Observational prospective clinical trial

PET/CT:
The FCH PET/CT scan will be combined with the multiphase CTscan that is
standard patient care for HCC.
The radiopharmacon is administered via the same route as the contrast agent of
the CTscan, and no allergies are known against this agent. The scan will take
an extra hour and will be performed three times over a period of approximately
9-12 months.

Bloodsamples:
Before every FCH PET/CT a bloodsample will be taken as is part of standard
patient care. (serum creatin and alpha fetoprotein)
During every FCH PET/CT a venous bloodsample is taken at 5, 10, and 15 minuts
post 18F-FCH injection, drawn from the intravenous line over which the 18F-FCH
was injected. No additional venous punction is necessary. The first 5 mL of the
first sample (t=5) will be disregarded and destroyed, 4mL will be used for
assessment of serum CRP levels by the LAKC, and 2mL will be used for assessment
of radioactivity. Additional assessment of radioactivity in the venous blood
will take place at t=10 and t=15 post 18F-FCH injection in 2mL whole blood.
Adding up to a total of 15mL blood per patient per scan.

Benefit:
Recurrence, metastases or progression of HCC could be recognized sooner, thus
making early adiquate therapy possible for the patients participating in the
trial or for patients with HCC in general.