Trial Outcomes & Findings for Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI (NCT NCT01433016)
NCT ID: NCT01433016
Last Updated: 2022-12-20
Results Overview
PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
At study day one after one hour
Results posted on
2022-12-20
Participant Flow
Participant milestones
| Measure |
Suspected HCC
Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI
Baseline characteristics by cohort
| Measure |
Suspected HCC
n=20 Participants
Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.
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|---|---|
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Age, Continuous
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64 years
STANDARD_DEVIATION 10.8 • n=5 Participants
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Sex: Female, Male
Female
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8 Participants
n=5 Participants
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Sex: Female, Male
Male
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12 Participants
n=5 Participants
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Region of Enrollment
Israel
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20 participants
n=5 Participants
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PRIMARY outcome
Timeframe: At study day one after one hourPDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.
Outcome measures
| Measure |
Suspected HCC
n=20 Participants
Subjects at high risk for Hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease
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|---|---|
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PDR Peak
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23.78 percentage of dose recovery
Standard Deviation 5.51
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Adverse Events
Suspected HCC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60