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

This is an interventional diagnostic trial for Adult Hepatocellular Carcinoma Read More

Inclusion Criteria:

1. Diagnosis of HCC with one or more of the following:

   1. Liver mass with non-rim arterial phase hyperenhancement (APHE) and one of the following:

      1. 10-19 mm with >= 2 additional major features according to LI-RADS criteria ("washout", enhancing "capsule", and/or threshold growth),
      2. 10-19 mm with "washout" and visibility at antecedent ultrasound (US) but with no "capsule" or threshold growth,

      3. 10-19 mm with >= 50% size increase in <= 6 months but with no "washout" or "capsule"

         or

      4. >= 20 mm with >= 1 additional major feature according to LI-RADS criteria ("washout", enhancing "capsule", or threshold growth).
   2. Suggestive imaging findings plus AFP > 200 mg/dL; or
   3. Tumor confirmed by arteriography. or

2. Diagnosis of a benign liver tumor with the following characteristics:

   1. Liver mass (>= 1 cm) that has suggestive imaging findings of a benign liver mass (adenoma, hemangioma, focal nodular hyperplasia).
   2. Prior SOC MRI of the benign liver lesion within 4 weeks of enrollment

   or

3. Diagnosis of a malignant non-HCC liver tumor with one or more of the following characteristics:

   1. Liver mass (>= 1 cm) that is biopsy proven metastatic disease (metastatic colorectal cancer, metastatic pancreatic cancer).
   2. Liver mass (>= 1 cm) that is a non-HCC primary malignancy (cholangiocarcinoma).
   3. Prior SOC MRI of the malignant non-HCC liver tumor within 4 weeks of enrollment

and

3. Each patient must have completed conventional imaging and staging and MRI before initiation of the investigational PET studies.

and

4. Patients with HCC or cholangiocarcinoma must be a candidate for liver resection or orthotopic liver transplant (OLT)

Exclusion Criteria:

1. Patients under the age of 18 will be excluded from this study.
2. Patients who have HCC or cholangiocarcinoma but are not candidates for liver resection surgery or OLT
3. Patients with a known prior malignancy who have received systemic chemotherapy within five years. 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 not excluded.
4. Pregnant and breastfeeding patients.
5. Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL).
6. Patients with a known Infiltrative variant of HCC.