Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis

NCT02794805 | Completed Phase 2

• 1 other identifier: HCC-MPBA-0514
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

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

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• 13CO2/12CO2 ratio

  60 minutes

Study Arms (2)

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.

Device: ¹³C-Octanoate Breath Test

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.

Device: ¹³C-Octanoate Breath Test

Interventions

¹³C-Octanoate Breath Test DEVICE

Octanoate Breath Test to be performed on subjects with suspected HCC

Also known as: Caprylate, Sodium caprylate

HCC negative; HCC positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patients with chronic liver disease at risk for HCC.
• Age ≥ 18 years.
• 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.
• Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.

You may not qualify if:

• Any patients with chronic liver disease at risk for HCC.
• Age ≥ 18 years.
• 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.
• Patient is naïve to HCC treatment (RFA or TACE or Oral HCC treatments) since last MRI.
• Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
• Women who are pregnant or breast feeding.
• 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.
• Patient, based on the opinion of the investigator, should not be enrolled into this study.
• Patient unable or unwilling to sign informed consent.
• Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (2)

302 Military Hopsital

Beijing, 100039, China

Location

General Hospital of Beijing Military Region

Beijing, 100700, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2016
• First Posted: June 9, 2016
• Study Start: June 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)