OBT Measurement to Differentiate Between Presence and Absence of HCC Determined by MRI

NCT ID: NCT02415283

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-12-31

Brief Summary

The Exalenz clinical investigation is a multicenter, non-randomized, study of the ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to evaluate the capability of the OBT to differentiate between presence and absence of HCC determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.

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.

Conditions

HCC

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HCC positive

¹³C-Octanoate Breath Test in 50 MRI proven HCC positive patients

¹³C-Octanoate Breath Test

Intervention Type: DEVICE

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

¹³C-Octanoate Breath Test in 50 MRI proven HCC negative patients

¹³C-Octanoate Breath Test

Intervention Type: DEVICE

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.

Interventions

¹³C-Octanoate Breath Test

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing 302 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongping Yang

Director of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

yongping yang, Prof

Role: PRINCIPAL_INVESTIGATOR

Cooperation

Central Contacts

Dan R Peres, MD

Role: CONTACT

danp@exalenz.com

Other Identifiers

HCC-MPBA-0514

Identifier Type: -

Identifier Source: org_study_id