Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02794805 | Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis | PHASE2 | COMPLETED | 74 | — | — | Jun 1, 2015 | Apr 1, 2017 | Dec 20, 2022 | 2 | China |
| 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...