Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
C-Octanoate Breath Test · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| HCC positive | EXPERIMENTAL | 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. |
| HCC negative | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| ¹³C-Octanoate Breath Test | DEVICE | Octanoate Breath Test to be performed on subjects with suspected HCC |
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 TA...
The ¹³C-Octanoate Breath Test is an investigational diagnostic being studied for use in Hepatocellular Carcinoma (HCC). It is being evaluated as a potential method to determine the presence of HCC, with one completed Phase 2 clinical trial comparing it against MRI diagnosis in 74 patients in China.
The ¹³C-Octanoate Breath Test is being developed by Meridian Bioscience Inc, a company traded under the ticker VIVO. The developer is conducting research on this diagnostic for Hepatocellular Carcinoma (HCC), with clinical development activity focused in China.
The ¹³C-Octanoate Breath Test is in Phase 2 clinical development for Hepatocellular Carcinoma (HCC). It is an investigational diagnostic and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and no trials are currently active.
The ¹³C-Octanoate Breath Test has one completed clinical trial, NCT02794805, titled 'Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis'. This Phase 2 study enrolled 74 participants with Hepatocellular Carcinoma (HCC) in China and was a controlled, non-randomized trial.
The ¹³C-Octanoate Breath Test is a specific diagnostic being studied for Hepatocellular Carcinoma (HCC). While octanoate breath tests exist for other purposes, this particular test is being evaluated for HCC detection, as shown in clinical trial NCT02794805 comparing it to MRI diagnosis.