18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant

PRIMARY OBJECTIVES:

I. To evaluate the relationship between 18F-FSPG PET/computed tomography (CT) and pathology
in patients with suspected hepatocellular carcinoma (HCC) scheduled for liver resection
surgery and orthotopic liver transplant (OLT).

II. To compare 18F-FSPG PET/CT with standard-of-care (SOC) diagnostic CT imaging in patients
with suspected HCC scheduled for liver resection surgery or OLT.

III. To compare the uptake of 18F-FSPG PET/CT with 11C-acetate PET/CT in suspected HCC and
background liver in patients scheduled for liver resection surgery or OLT.

IV. To evaluate uptake of 18F-FSPG PET/CT in non-HCC liver tumors: benign and malignant
compared to background.

OUTLINE:

Patients undergo 18F-FSPG PET and carbon-11 (11C)-acetate PET scans within 4-8 weeks of
surgery or OLT.

Inclusion Criteria:

- Diagnosis of HCC with clinically documented cirrhosis and one or more of the
following:

- Liver mass (>= 1 cm) with arterial phase contrast enhancement and early washout
on subsequent phases by CT; or

- Suggestive imaging findings plus alpha-feto protein (AFP) > 200 mg/dL; or

- Tumor confirmed by arteriography -or-

- Diagnosis of a non-HCC liver mass with one or more of the following:

- Liver mass (≥ 1 cm) that has suggestive imaging findings of a benign liver mass
(adenoma, hemangioma, focal nodular hyperplasia).

- Liver mass (≥ 1 cm) that is biopsy proven metastatic disease (metastatic
colorectal cancer, metastatic pancreatic cancer).

- Liver mass (≥ 1 cm) that is a non-HCC primary malignancy (cholangiocarcinoma).
-and-

- Each patient must provide written informed consent and have completed conventional
imaging and staging and CT (multiphase) or MRI before initiation of the
investigational PET studies

Exclusion Criteria:

- Patients with a known prior malignancy who have received systemic chemotherapy within
five years, except basal cell carcinoma of the skin, carcinoma in situ of the cervix,
prior HCC, and patients with liver mass(es) proven to be metastatic disease are
excluded.

- Pregnant and breastfeeding patients

- Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200
mg/dL)

- Patients with a known infiltrative variant of HCC