In short
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.
At a glance
- 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
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.
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:
- 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:
- 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:
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:
- Primary Objective: Assess the diagnostic accuracy of the OWL-EVO1 Breath Biopsy test in differentiating between individuals with and without lung cancer.
- 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:
- 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:
- 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.