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

NCT02415283 | Unknown DMC

• 1 other identifier: HCC-MPBA-0514
• Study Type: observational
• Target: 2
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

• 13CO2/12CO2 ratio

  60min

Study Arms (2)

HCC positive

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

Device: ¹³C-Octanoate Breath Test

HCC negative

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

Device: ¹³C-Octanoate Breath Test

Interventions

¹³C-Octanoate Breath Test 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; HCC positive

Eligibility Criteria

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

Study Population

The proposed study will include subjects with chronic liver disease of any cause at risk for HCC with MRI results within 3 months prior to OBT or scheduled for MRI within the time frame of the study, and who meet the inclusion criteria and none of the exclusion criteria.

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

• Beijing 302 Hospital: lead

Study Officials

• yongping yang, Prof

  Cooperation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan R Peres, MD

CONTACT

danp@exalenz.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 14, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 14, 2015

Record last verified: 2015-04