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Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer


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

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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:

Interventional

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:

No

Principal Investigator

Sandi Kwee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Queen's Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

RA-2011-025

NCT ID:

NCT01395030

Start Date:

July 2011

Completion Date:

July 2016

Related Keywords:

  • Liver Cancer
  • Liver
  • Cancer
  • Liver Neoplasms

Name

Location
The Queen's Medical Center Honolulu, Hawaii  96813