Adult Hepatocellular Carcinoma Clinical Trial
Official title:
Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer
Verified date | August 2018 |
Source | Queen's Medical Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial studies positron emission tomography (PET)/computed tomography (CT) in diagnosing patients with liver cancer undergoing surgical resection. Diagnostic procedures, such as fluorine-18 fluoromethylcholine PET/CT, may help find and diagnose liver cancer.
Status | Completed |
Enrollment | 64 |
Est. completion date | May 31, 2018 |
Est. primary completion date | May 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Liver tumor diagnosed histologically as HCC or suspected of being HCC in association with serum alpha-fetoprotein level > 200 or tumor mass with characteristics of malignancy on diagnostic imaging - Under the care of a surgical attending - Deemed 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 - Pregnant or lactating female, a serum pregnancy test will be performed within 2 weeks or less before the date of the FCH PET/CT scan in all women capable of becoming pregnant - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Hawaii Cancer Center | Honolulu | Hawaii |
Lead Sponsor | Collaborator |
---|---|
Queen's Medical Centre | National Cancer Institute (NCI) |
United States,
Kwee SA, Wong L, Chan OTM, Kalathil S, Tsai N. PET/CT with (18)F Fluorocholine as an Imaging Biomarker for Chronic Liver Disease: A Preliminary Radiopathologic Correspondence Study in Patients with Liver Cancer. Radiology. 2018 Apr;287(1):294-302. doi: 10 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve. | Area under the receiver operating characteristic curve for detecting resectable hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax). | Up to study completion at an average of 2.5 years | |
Primary | Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Sensitivity/Specificity | Sensitivity and specificity estimated at a predefined point (ie. Youden's maxima) on the receiver operating characteristic curve for detecting hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax) in patients who underwent subsequent tumor resection. | Up to study completion at an average of 2.5 years | |
Primary | Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples. | Statistically significant enrichment by sets of genes corresponding to previously-defined molecular pathway signatures was assessed by gene set enrichment analysis (a publicly available algorithm) of whole-genome expression array data obtained from tumors previously characterized by FCH PET/CT. Statistical significance was based on a false discovery rate < 0.05. Tumors demonstrating high choline metabolism (defined by a tumor-liver ratio > 1.0 measured on PET) were assessed for enrichment by publicly-available gene sets. This particular analysis involved the entire Molecular Hallmarks gene signature collection (v6.0) as obtained from the Broad Institute Molecular Signature Database (MSigDB). | Up to study completion at an average of 2.5 years | |
Primary | Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage | Odds ratios and 95% confidence intervals for histologic liver fibrosis (Metavir) stage >= F1, >= F2, >= F3, and F4 at liver standardized uptake value (SUV) thresholds of 8.3, 8.0, 7.4, and 6.4, respectively. Reference: PMID 29315063. | Up to 1 year | |
Primary | Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes | HCC tumors were sub-classified using gene expression arrays into 3 distinct prognostically-relevant molecular sub-classes (S1,S2, S3, where S3 is associated with the most favorable clinical prognosis) based on Hoshida et. al (PMID 19723656). The number of tumors comprising two distinct PET/CT imaging phenotypes (high FCH uptake vs. low FCH uptake) was compared between the different sub-classes. | Up to study completion at an average of 2.5 years |
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