Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI

NCT01433016 | Terminated Phase 2 Results

• 1 other identifier: HCC-BID-0411
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 measurement to differentiate between presence and absence of HCC determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.

Conditions

Chronic Liver Disease; Hepatocellular Carcinoma (HCC)

Keywords

HCC Hepatocellular carcinoma; OBT Octanoate Breath Test

Outcome Measures

Primary Outcomes (1)

• PDR Peak

  PDR peak - the rate at which the 13C labeled substrate is metabolized, percentage dose recovery.

  At study day one after one hour

Study Arms (1)

Octanaote Breath Test

EXPERIMENTAL

A Octanoate breath test will be performed on this single arm population

Drug: 13C Sodium Octanoate

Interventions

13C Sodium Octanoate DRUG

13C labeled Sodium Octanoate Substrate is provided in powder form in doses of 100mg for single breath test, and is dissolved in 150cc of tap water before ingestion. Duration of the observation after the drug ingestion is one hour.

Octanaote Breath Test

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 any HCC treatment.

You may not qualify if:

• Underwent any RFA or TACE or Oral HCC treatments.
• Portal vein thrombosis.
• Prior TIPS placement.
• Severe congestive heart failure (LVEF on echocardiogram \< 20%).
• Severe pulmonary hypertension (By echocardiogram, PAS \>45 mmHg).
• Uncontrolled diabetes mellitus (HBA1C \>9.5%).
• Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.
• Previous surgical bypass surgery for morbid obesity (BMI \>45).
• Extensive small bowel resection.
• Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs.
• Women who are pregnant or breast feeding.
• Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma.
• Patient has taken 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 is unable or unwilling to sign informed consent.

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead
• Toronto General Hospital: collaborator
• Medical University of South Carolina: collaborator
• Northwestern University: collaborator
• Henry Ford Health System: collaborator
• Hadassah Medical Organization: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

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

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed.

Results Point of Contact

• Title: Clinical Trials Manager
• Organization: Exalenz Bioscience

avrahamh@exalenz.com

+972-8-9737513

Study Officials

• Morris Sherman, MD

  Toronto General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2011
• First Posted: September 13, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2013
• Last Updated: December 20, 2022
• Results First Posted: April 7, 2014

Record last verified: 2022-12

Locations

CA (1)