Clinical trial · Interventional
Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis
Evaluation of the Capability of the ¹³C-Octanoate Breath Test (OBT) Measurement to Differentiate Between Presence and Absence of HCC Determined by MRI in Patients With Chronic Liver Disease
NCT02794805CI-TRIAL-00062778completedPhase 2ClinicalTrials.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)
An Octanoate breath test will be used to assess the presence of Hepatocellular Carcinoma in subjects with risk. The gold standard will be MRI.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ¹³C-Octanoate Breath Test | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HCC positive
- description
- Breath testing utilizing 13C is a safe, non-invasive means for measuring a certain pathway's metabolic rate. 13C is a stable, non-radioactive isotope which can be incorporated into a specific location within a test substrate so it would be released when the compound is metabolized by the liver. Hepatic metabolism of the compound is assessed by measuring the ratio of 13CO2/12CO2 in exhaled breath.
- interventionNames
- Device: ¹³C-Octanoate Breath Test
- type
- EXPERIMENTAL
- label
- HCC negative
- description
- Breath testing utilizing 13C is a safe, non-invasive means for measuring a certain pathway's metabolic rate. 13C is a stable, non-radioactive isotope which can be incorporated into a specific location within a test substrate so it would be released when the compound is metabolized by the liver. Hepatic metabolism of the compound is assessed by measuring the ratio of 13CO2/12CO2 in exhaled breath.
- interventionNames
- Device: ¹³C-Octanoate Breath Test
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Any patients with chronic liver disease at risk for HCC. 2. Age ≥ 18 years. 3. Patient has an MRI result (positive or negative for HCC) up to 3 months prior to recruitment or will be scheduled for an MRI during the trial period. 4. Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI. Exclusion Criteria: 1. Any patients with chronic liver disease at risk for HCC. 2. Age ≥ 18 years. 3. Patient has an MRI result (positive or negative for HCC) up to 3 months prior to recruitment or will be scheduled for an MRI during the trial period. 4. Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI. 5. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs. 6. Women who are pregnant or breast feeding. 7. Patient taking drugs that can interfere with octanoate metabolism or can also cause NAFLD independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine. 8. Patient, based on the opinion of the investigator, should not be enrolled into this study. 9. Patient unable or unwilling to sign informed consent. 10. Patients that are participating in other clinical trials evaluating experimental treatments or procedures
References
Publications (0)
Data not yet available
No reference posted for this study.