Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer
Conditions
Liver Cancer
Conditions: official terms
Liver Neoplasms
Conditions: Keywords
Liver, Cancer
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: Fluoromethylcholine (FCH) PET/CT Imaging
Type: Drug
Overall Status
Recruiting
Summary
Altered choline phospholipid metabolism is a recently recognized hallmark of cancer and potential diagnostic and therapeutic target in a number of cancers, including hepatocellular carcinoma (HCC). The feasibility of detecting HCC on the basis of measuring the phosphorylation rate of choline in-vivo has been shown using positron emission tomography/computed tomography (PET/CT) and the investigational tracer compound [18F] fluorocholine (FCH). This Phase 2 study will evaluate the diagnostic performance of FCH PET/CT in patients undergoing surgical resection as treatment for HCC. Since the molecular signaling alterations leading to enhanced choline metabolism in tumors are not fully elucidated at this time, this study will also collect frozen tissue specimens for whole-genome gene expression profiling to elucidate genes and signal transduction pathways related to altered choline metabolism in HCC.
Detailed Description
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. The surgical procedures are clinically warranted and not considered a part of the investigation.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
The Queen's Medical Center
Honolulu, Hawaii, United States
Status: Recruiting
Contact: Miles Sato, MS - 808-691-5466 - msato@queens.org
Start Date
July 2011
Completion Date
July 2017
Sponsors
Queen's Medical Centre
Source
Queen's Medical Centre
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page