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Determination of HCC With Octanoate Breath Test vs. MRI Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02794805
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma (HCC) Device: ¹³C-Octanoate Breath Test Phase 2

Detailed Description:
  1. Informed consent will be obtained from all patients prior to enrollment.
  2. The trial will be conducted in compliance with this protocol, with GCP standards, and the applicable regulatory requirements.
  3. This study will be cross-sectional, where patients will be enrolled on a walk in basis. Once one arm is completed the other one will be enriched in order to obtain at least 50 positive and at least 50 negative HCC subjects as defined by MRI.
  4. All patients will undergo AFP and US if they do not have results within the past three months.
  5. If the patient undergoes liver FNA, the biopsy results will be evaluated for the presence of HCC.
  6. For all patients, a case report form will be completed.
  7. All patients will undergo a physical examination, and their medical history/concomitant medications, weight, height and age will be recorded. Furthermore, recent (past 3 months) blood test results, if available, may be recorded.
  8. If relevant (woman of child bearing age), a pregnancy test will be performed to rule out pregnancy when performing the breath test.
  9. All MRI negative patients with low OBT results will undergo additional MRI within 6 to 12 months post OBT to rule out HCC occurrence.
  10. If available, all additional MRI/CT/US results will be recorded within the patient's CRF.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : June 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HCC positive
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
Octanoate Breath Test to be performed on subjects with suspected HCC
Other Names:
  • Caprylate
  • Sodium caprylate

Experimental: HCC negative
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
Octanoate Breath Test to be performed on subjects with suspected HCC
Other Names:
  • Caprylate
  • Sodium caprylate




Primary Outcome Measures :
  1. 13CO2/12CO2 ratio [ Time Frame: 60 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02794805


Locations
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China
302 Military Hopsital
Beijing, China, 100039
General Hospital of Beijing Military Region
Beijing, China, 100700
Sponsors and Collaborators
Exalenz Bioscience LTD.
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Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT02794805    
Other Study ID Numbers: HCC-MPBA-0514
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases