Phase 2
N=64
PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection
Adult Hepatocellular Carcinoma · Localized Resectable Adult Liver Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01395030 ↗Enrolled (actual)
64
Serious AEs
3.1%
Results posted
Sep 2018
Primary outcome: Primary: Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve. — 0.87; 0.80 unitless
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Computed Tomography (Diagnostic_test); 18F-fluoromethylcholine (Drug); Positron Emission Tomography (Diagnostic_test)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Queen's Medical Center
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve. |
0.87; 0.80 | — |
| PRIMARY Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Sensitivity/Specificity |
100; 73 | — |
| PRIMARY Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples. |
0.009; 0.012; 0.012; 0.014; 0.015; 0.016 | — |
| PRIMARY Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage |
3.03; 5.29; 5.56; 6.67 | — |
| PRIMARY Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes |
7; 6; 0; 4; 24; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01395030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.