Phase 2
Completed N=64
PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection
Source: ClinicalTrials.gov NCT01395030 ↗Enrolled (actual)
64
Serious AEs
3.1%
Results posted
Sep 2018
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.