Know Cancer

forgot password

Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Liver Cancer

Thank you

Trial Information

Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer

Eighty (80) human subjects with hepatocellular carcinoma (HCC) who meet selection criteria
will undergo PET/CT imaging with 18F-fluoromethylcholine (FCH or 18F-choline) prior to
surgical hepatic resection. The PET/CT will measure the dynamic tissue delivery and uptake
of 18F-choline in the liver, as well as its static distribution in this organ after a fixed
period of time. Kinetic modeling will be performed using the PET/CT data to quantify
parameters related to 18F-choline delivery, uptake, and phosphorylation. The imaging
findings will be compared with histopathologic diagnosis following surgery to estimate the
detection rate and other diagnostic parameters of PET/CT for HCC. Tumor and liver tissue
samples will also be obtained following surgery for gene expression analysis. These results
will be correlated with the imaging findings.

Inclusion Criteria:

- liver tumor diagnosed by histology as HCC or suspected of being HCC in association
with serum alpha-fetoprotein level > 200 or with characteristics of malignancy on
diagnostic imaging

- under the care of a surgical attending

- deemed to be a surgical candidate and has agreed to surgery to remove a portion of
the liver containing tumor

- Child-Pugh A/B

Exclusion Criteria:

- Weight > 350 lbs (PET/CT limit)

- pregnant or lactating female

- serious underlying medical condition that would impair patient's ability to tolerate
the imaging procedure

- concurrent treatment with chemotherapy, molecule-selective, biological, or
radiotherapeutic agent

- transplant candidate

Type of Study:


Study Design:

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Histopathologic Diagnosis - estimate detection rate and other diagnostic parameters of PET/CT for hepatocellular carcinoma (HCC)

Outcome Time Frame:

5 years - Longitduinal Data Collection

Safety Issue:


Principal Investigator

Sandi Kwee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Queen's Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2011

Completion Date:

July 2016

Related Keywords:

  • Liver Cancer
  • Liver
  • Cancer
  • Liver Neoplasms



The Queen's Medical CenterHonolulu, Hawaii  96813