Clinical trial · Interventional
PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection
Genomic and Imaging Study for Patients Undergoing Surgery for Liver Cancer
NCT01395030CI-TRIAL-00035038completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Localized Resectable Adult Liver Carcinoma | Adult Liver Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-fluoromethylcholine | Drug | — | UNRESOLVED |
| Computed Tomography | Diagnostic Test | — | UNRESOLVED |
| Positron Emission Tomography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-fluoromethylcholine PET/CT
- description
- Patients undergo 18F-fluoromethylcholine positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection of liver tumor.
- interventionNames
- Diagnostic Test: Computed Tomography
- Drug: 18F-fluoromethylcholine
- Diagnostic Test: Positron Emission Tomography
Primary outcomes (5)
- measure
- Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve.
- timeFrame
- Up to study completion at an average of 2.5 years
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTKwee SA, Wong L, Chan OTM, Kalathil S, Tsai N. PET/CT with 18F 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: 10.1148/radiol.2018171333. Epub 2018 Jan 9. PMID 29315063