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

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying lung cancer and involves a new test called the OWL-EVO1 Breath Biopsy test. The test aims to help differentiate between individuals who may have lung cancer and those who do not. The study will use a special solution called D5-ethyl-beta-D-glucuronide, which is given through an infusion into the veins. This solution is a water-soluble substance that helps in the testing process.

The purpose of the study is to assess how accurately the OWL-EVO1 test can identify lung cancer in people who are undergoing screening or have findings on a CT scan that might suggest lung cancer. Participants will receive the test and be monitored to see how well it works in identifying lung cancer compared to other conditions that might look similar on a scan. The study will also look at the safety and tolerability of the test, ensuring that it is safe for participants to use.

Throughout the study, participants will receive the test and be observed over a period of time to gather information on its effectiveness and safety. The study will help determine if the OWL-EVO1 test can be a reliable tool for diagnosing lung cancer, potentially leading to earlier and more accurate detection of the disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age (45-85 years), ability to provide informed consent, body mass index (BMI) between 16 and less than 40, and having received a CT scan of the thoracic region within the last 6 months.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline health information and confirm eligibility criteria. This includes reviewing recent CT scan results and other relevant medical history.

  3. Step 3

    Administration of OWL-EVO1

    The study involves the administration of OWL-EVO1, a solution for infusion, given intravenously. The specific dosage and frequency are determined based on the study protocol, which aims to evaluate the diagnostic accuracy of the OWL-EVO1 Breath Biopsy test.

  4. Step 4

    Breath sampling

    Breath samples are collected at various timepoints to assess the effectiveness of the OWL-EVO1 test in differentiating between individuals with lung cancer and those without. The sampling process includes evaluation of method, sampling timepoints, posture, and duration of breath samples.

  5. Step 5

    Monitoring and follow-up

    Participants are monitored for any adverse events related to the administration of OWL-EVO1. Safety and tolerability are assessed throughout the study duration.

  6. Step 6

    Completion of study

    The study is estimated to conclude by August 30, 2024. Upon completion, participants may receive information about the study findings and any implications for their health.

Who can join the trial?

4 criteria

  • Must be between the ages of 45 and 85 years old.
  • Must be able to understand the study and agree to participate by signing a consent form. This is called providing informed consent.
  • Must have a BMI (Body Mass Index) between 16 and less than 40. BMI is a number calculated from a person's weight and height to indicate if they are underweight, normal weight, overweight, or obese.
  • Must have had a CT scan (a special type of X-ray) that includes the chest area within the last 6 months.

Who cannot join the trial?

3 criteria

  • Individuals who are not eligible for lung cancer screening based on low dose CT scans.
  • Individuals without incidental findings on a CT scan that are suspicious of lung cancer.
  • Individuals whose clinical presentations do not include lung cancer as part of their differential diagnosis. A differential diagnosis is a list of possible conditions or diseases that could be causing a person's symptoms.
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Investigated drugs

OWL-EVO1: This is a diagnostic test used in the study to help identify lung cancer. It works by analyzing breath samples to detect specific markers that may indicate the presence of lung cancer. The goal is to improve the accuracy of diagnosing lung cancer in individuals who are undergoing screening or have suspicious findings on a CT scan.

What is already known about the treatment

OWL-EVO1 – This medication is administered as a breath biopsy test, designed to be non-invasive and easy to use. Currently, it is under clinical investigation for its diagnostic accuracy in identifying lung cancer. The main therapeutic indication is to differentiate between individuals with lung cancer and those with similar clinical presentations. At the molecular level, it works by analyzing volatile organic compounds in the breath, which can indicate the presence of cancer. It falls under the pharmacological classification of diagnostic agents.

Investigated diseases

Lung Cancer – Lung cancer is a disease characterized by the uncontrolled growth of abnormal cells in one or both lungs. These abnormal cells do not develop into healthy lung tissue; instead, they divide rapidly and form tumors. As the tumors grow, they can interfere with the lung's ability to provide oxygen to the bloodstream. The disease can start in different parts of the lung, such as the bronchi, bronchioles, or alveoli. Over time, lung cancer can spread to other parts of the body, a process known as metastasis. The progression of lung cancer can vary greatly depending on the type and stage of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503574-20-00Protocol codeOML-EV2-2.1_EUEstimated enrolment175 patientsSponsorOwlstone Medical Limited

sourced from the EU Clinical Trials Register and site verification

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