Clinical trial · Observational
FDGal PET/CT to Detect Hepatocellular Carcinoma
A Single-blind Study to Evaluate the Efficacy and Safety of 18F-Fluorodeoxygalactose (18F-FDGal) Compared to 18F-Fluorodeoxyglucose (18F-FDG) to Detect Hepatocellular Carcinoma Via PET/CT in Patients With Cirrhosis or Chronic Liver Disease
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PIs will not pursue trial due to staff and time constraints
Summary
Brief summary (as posted)
Liver cancer is one of the leading causes of cancer death among Asian men. If diagnosed early the disease is treatable with surgery. Current conventional imaging modalities have limitations to early detection. This study proposes to use 18F-FGal and 18F-FDG PET/CT scans to compare the clinical efficacy of diagnosing hepatocellular carcinoma (a type of liver cancer) using these PET/CT scans.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Liver Disease | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic PET/CT scans | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity of 18F-FDGal in the diagnosis of HCC on per-patient basis
- timeFrame
- 6 months
- description
- Determination of sensitivity of both exams when compared with pathology reports (if available) and compared with routine imaging (CT, MRI, US) if available. The treatment group will be declared superior if the lower limit of the 95% two-sided confidence interval of the difference of these two proportions is greater than 0.
Secondary outcomes (3)
- measure
- Number of participants with 18F-FDGal-related adverse events as assessed by abnormal vital sign measurement
- timeFrame
- 1 hour
- description
- Vital signs (blood pressure, heart rate and pulse oximetry) will be measured at three time points (before and after injection, and 1 hour after the injection). All values that fall outside of the normal parameters will be assessed by a physician and reported as an adverse event.
- measure
- Sensitivity of 18F-FDGal in the diagnosis of HCC on per-site basis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female, age ≥ 19 years of age. * Patient who accepts to enter the study by signing written informed consent. * Patient with performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG). * Patient with cirrhosis or chronic liver disease suspected to have at least 1 hepatic nodule larger than 1 cm in diameter detected by conventional image (US, CT, MRI). * Hepatic nodule is defined as any one of the following conditions: suspicious hepatocellular carcinoma, benign tumor such as hemangioma, adenoma or focal nodular hyperplasia, possible metastatic lesions from other primary malignancy. Exclusion Criteria: * Patient has serious allergic history or known allergy to 18F-FDGal or 18F-FDG. * Patient has received therapy for aforementioned diagnosis before the PET scans * Patient with known (proven) metastases from a prior malignancy * Patient has been diagnosed with multiple malignancies. * Female patient who is pregnant, lactating or planning to become pregnant during the study. * Patient has participated in other investigational trials within 28 days prior to study enrollment. * Inability to lie supine for the duration of the imaging studies. * Subject with active systemic infections, or medical conditions that may significantly affect adequate uptake and elimination of radiotracer. * Subject with conditions judged by the investigator as unsuitable for the study.
References
Publications (0)
Data not yet available