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D5-Ethyl-Beta-D-Glucuronide

A new clinical trial is underway to assess the effectiveness of a breath-based diagnostic test for lung cancer using D5-Ethyl-Beta-D-Glucuronide. This study, known as the OWL-EVO1 Breath Biopsy test, aims to differentiate between individuals with lung cancer and those without, potentially offering a less invasive alternative to current diagnostic methods. The trial will evaluate the test’s accuracy, optimize its parameters, and assess the safety and tolerability of the compound used.

Table of Contents

Introduction to OWL-EVO1

OWL-EVO1 is an innovative Breath Biopsy test being studied for its potential to diagnose lung cancer. This test is designed to analyze compounds in a person’s breath to detect signs of lung cancer, offering a potentially less invasive alternative to traditional diagnostic methods.[1]

Purpose of the Study

The main goal of this clinical trial is to assess how accurately the OWL-EVO1 Breath Biopsy test can distinguish between individuals with lung cancer and those without. The study focuses on two specific groups:[1]

  • People eligible for lung cancer screening based on low-dose CT scans, with or without lung cancer
  • Individuals with incidental findings on CT scans that are suspicious for lung cancer

Target Conditions

The study aims to evaluate the OWL-EVO1 test’s effectiveness in detecting various types and stages of lung cancer, including:[1]

  • Small cell lung cancer: A fast-growing type of lung cancer
  • Large cell lung cancer: A type of non-small cell lung cancer
  • Adenosquamous cell lung cancer: A rare type of lung cancer with mixed cell types

The study includes patients with different stages of these cancers, from early (stage 0) to advanced (stage IV) and recurrent cases.

Eligibility Criteria

To participate in this study, individuals must meet certain criteria:[1]

Inclusion Criteria:

  • Age between 45 and 85 years
  • Ability to provide informed consent
  • Have had a CT scan including the chest area within the last 6 months

Exclusion Criteria:

  • Inability to complete the breath sampling procedure
  • Lack of mental capacity to participate
  • Recent participation in other clinical trials
  • Ongoing investigation for other potential cancers
  • History of certain lung surgeries or procedures
  • Pregnancy or breastfeeding

Study Objectives

The clinical trial has several key objectives:[1]

  1. Primary Objective: Assess the diagnostic accuracy of the OWL-EVO1 Breath Biopsy test in differentiating between individuals with and without lung cancer.
  2. Secondary Objectives:
    • Optimize the test parameters (dose, timing, and duration of breath sampling) to maximize accuracy and tolerability
    • Evaluate the safety and tolerability of OWL-EVO1

Drug Information: D5-ETHYL-BETA-D-GLUCURONIDE

The study uses a drug called D5-ETHYL-BETA-D-GLUCURONIDE, also known as OWL-EVO2. Here are some key points about this substance:[1]

  • It is a deuterium-labeled form of ethyl-β-D-glucuronide, a water-soluble direct metabolite of ethanol
  • Administered as a solution for intravenous (IV) infusion
  • Maximum daily dose: 2 mg/kg
  • Maximum treatment period: 2 days

This compound is used to help detect specific markers in the breath that may indicate the presence of lung cancer.

Potential Benefits and Considerations

While the OWL-EVO1 Breath Biopsy test is still under investigation, it offers several potential benefits:[1]

  • Non-invasive: As a breath test, it may be less invasive than traditional biopsy methods
  • Early detection: It could potentially help in earlier diagnosis of lung cancer
  • Versatility: The test is being studied for various types and stages of lung cancer

However, it’s important to note that this is a Phase II study, meaning the test is still in the evaluation stage. More research is needed to confirm its effectiveness and safety for widespread use in diagnosing lung cancer.

Aspect Details
Trial Name Diagnostic Accuracy Study for OWL-EVO1 as a Lung Cancer EVOC® Probe
Trial Category Phase II study
Main Objective Assess diagnostic accuracy of OWL-EVO1 Breath Biopsy test for lung cancer
Secondary Objectives Optimize test parameters, assess safety and tolerability
Eligibility Age Range 45-85 years
Key Inclusion Criteria Recent CT scan of thoracic region, ability to provide informed consent
Key Exclusion Criteria Inability to complete breath sampling, recent participation in other clinical trials
Active Substance D5-Ethyl-Beta-D-Glucuronide
Administration Route Intravenous use
Maximum Daily Dose 2 mg/kg
Primary Endpoint Diagnostic accuracy measured by ROC curve, AUC, NPV, PPV, Sensitivity, and Specificity

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to assess the diagnostic accuracy of the OWL-EVO1 Breath Biopsy test in differentiating between individuals with lung cancer and those without, particularly in cases where lung cancer is part of the differential diagnosis.
  • Who can participate in this trial? Participants must be between 45-85 years old, able to provide informed consent, and have received a CT scan of the thoracic region within the last 6 months. However, there are several exclusion criteria, such as inability to complete the breath sampling procedure or recent participation in other clinical trials.
  • What is D5-Ethyl-Beta-D-Glucuronide and how is it used in this trial? D5-Ethyl-Beta-D-Glucuronide is a deuterium-labeled compound used as the active substance in this trial. It is administered intravenously, and its presence in breath samples is analyzed to potentially detect lung cancer.
  • What are the secondary objectives of this trial? Secondary objectives include optimizing the OWL-EVO1 test parameters (such as dose, timing, and breath sampling duration) to maximize diagnostic accuracy and tolerability, as well as assessing the safety and tolerability of D5-Ethyl-Beta-D-Glucuronide.
  • How will the diagnostic accuracy be measured? The diagnostic accuracy will be reported using a Receiver Operator Characteristic (ROC) curve, Area Under the Curve (AUC), negative predictive value (NPV), positive predictive value (PPV), sensitivity, and specificity. These metrics will be reported for overall test performance and pre-defined subgroup analyses.

Ongoing Clinical Trials on D5-Ethyl-Beta-D-Glucuronide

  • Study on the Accuracy of OWL-EVO1 Test for Diagnosing Lung Cancer in Patients Eligible for Screening or with Suspicious CT Findings

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Hungary

Glossary

  • D5-Ethyl-Beta-D-Glucuronide: A deuterium-labeled compound used as the active substance in this trial, administered intravenously to detect lung cancer through breath analysis.
  • OWL-EVO1 Breath Biopsy test: A non-invasive diagnostic test that analyzes breath samples to potentially detect lung cancer.
  • Diagnostic accuracy: The ability of a test to correctly identify patients with and without a specific condition.
  • Receiver Operator Characteristic (ROC) curve: A graphical plot that illustrates the performance of a diagnostic test at various threshold settings.
  • Area Under the Curve (AUC): A measure of the overall performance of a diagnostic test, with values closer to 1 indicating better performance.
  • Negative Predictive Value (NPV): The probability that a person with a negative test result truly doesn't have the condition.
  • Positive Predictive Value (PPV): The probability that a person with a positive test result truly has the condition.
  • Sensitivity: The ability of a test to correctly identify patients with a disease.
  • Specificity: The ability of a test to correctly identify patients without a disease.
  • Differential diagnosis: A process of distinguishing between multiple potential conditions that share similar symptoms.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Adverse Events: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.

References

  1. http://clinicaltrials.eu/trial/study-on-the-accuracy-of-owl-evo1-test-for-diagnosing-lung-cancer-in-patients-eligible-for-screening-or-with-suspicious-ct-findings/