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

This study has been terminated.
(Due to budgetary issues, the company has decided to focus on other applications at this stage.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01433016
First Posted: September 13, 2011
Last Update Posted: April 25, 2014
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.
Collaborators:
Toronto General Hospital
Medical University of South Carolina
Northwestern University
Henry Ford Health System
Hadassah Medical Organization
Information provided by (Responsible Party):
Exalenz Bioscience LTD.
Results First Submitted: February 11, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Chronic Liver Disease
Hepatocellular Carcinoma (HCC)
Intervention: Drug: 13C Sodium Octanoate

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Suspected HCC Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.

Participant Flow:   Overall Study
    Suspected HCC
STARTED   20 
COMPLETED   20 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Cirrhotic patients with suspected HCC

Reporting Groups
  Description
Suspected HCC Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.

Baseline Measures
   Suspected HCC 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Standard Deviation)
 64  (10.8) 
Gender 
[Units: Participants]
 
Female   8 
Male   12 
Region of Enrollment 
[Units: Participants]
 
Israel   20 


  Outcome Measures

1.  Primary:   PDR Peak   [ Time Frame: At study day one after one hour ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects analyzed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Trials Manager
Organization: Exalenz Bioscience
phone: +972-8-9737513
e-mail: avrahamh@exalenz.com



Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT01433016     History of Changes
Other Study ID Numbers: HCC-BID-0411
First Submitted: September 11, 2011
First Posted: September 13, 2011
Results First Submitted: February 11, 2014
Results First Posted: April 7, 2014
Last Update Posted: April 25, 2014