Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe (Evolution Phase 2)

October 10, 2024 updated by: Owlstone Ltd

Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe

The Phase 2a Evolution study aims to assess the diagnostic accuracy of the OWL-EV1 Probe Breath Biopsy Test to differentiate between individuals with lung cancer and relevant contrast groups.

The contrast groups will be representative of the clinical populations in which the test is intended to be used.

Thus, Evolution Phase 2a will be designed as a cross-sectional, case-control trial that will be conducted at various sites, both in the UK and EU.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In Evolution Phase 1, Owlstone Medical demonstrated the safety and tolerability of their Exogenous Volatile Organic Compound (EVOC) Probe. This phase also demonstrated proof of mechanism for the cleavage of the EVOC Probe, D5-ethyl-βD-glucuronide (OWL-EVO1), into D5-ethanol which can be detected on breath. This makes OWL-EVO-1 a promising EVOC Probe for the detection of lung cancer.

The Evolution Phase 2a study will evaluate the diagnostic accuracy of an OWL-EVO1 based breath test for the differentiation of those with histopathologically confirmed lung cancer and relevant contrast groups with a CT-proven absence of lung cancer. These contrast groups will include those with relevant comorbidities, to truly evaluate accuracy and the robustness of test performance.

As a secondary objective, the study aims to define a test protocol that minimises healthcare worker effort, whilst maximising tolerability and diagnosed accuracy for the intended use setting.

This phase intends to recruit up to 150 cases and 200 controls. Both cohorts will be administered the probe intravenously. Multiple breath samples will be collected for up to 180 minutes post-probe infusion, with the cumulative sampling time not exceeding 60 minutes.

The study results will provide valuable insights into the expected test performance as well as optimisation of the test in a clinical pathway.

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Prague, Czechia, 140 59
        • Recruiting
        • Thomayer Hospital
        • Contact:
        • Contact:
          • Dr Marie Drosslerova
  • Hungary
      • Budapest, Hungary, H-1121
        • Not yet recruiting
        • National Koranyi Institute For Pulmonology
        • Contact:
        • Contact:
          • Dr Ildiko Horvath
      • Debrecen, Hungary, H-4032
        • Recruiting
        • Department of Pulmonology, University of Debrecen
        • Contact:
          • Dr Ildiko Horvath
  • United Kingdom
      • London, United Kingdom, E1 1FR
        • Not yet recruiting
        • Barts Health NHS Trust
        • Contact:
        • Contact:
          • Dr William Ricketts
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Imperial Centre for Translational and Experimental Medicine, Imperial College
        • Contact:
        • Contact:
        • Contact:
          • Dr Susannah Bloch
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0AY
        • Recruiting
        • Royal Papworth Hospital NHS Foundation Trust
        • Contact:
        • Contact:
        • Contact:
          • Dr Laura Succony
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M23 9LT
        • Recruiting
        • Wythenshawe Hospital
        • Contact:
        • Contact:
        • Contact:
          • Professor Philip Crosbie
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE3 9QP
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UQ

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 45-85 years.
  • Ability to provide informed consent.
  • BMI 16 - <40.
  • Receiving a CT including the thoracic region, within the last 6 months.

Exclusion Criteria:

  1. (Anticipated) inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation unaided or claustrophobia).
  2. Potential subjects who in the opinion of the investigator lack mental capacity.
  3. Received an investigational medical product in the context of a Clinical Trial (CTIMP) during the 28 days prior to administration of the (first) probe, or within 5 times the half-life of the investigational medicinal product previously received, whichever is longer.*
  4. Individuals under diagnostic investigation for a potential malignancy other than lung cancer that has not yet reached a conclusive diagnosis**.
  5. Individuals with an inconclusive lung abnormality (indeterminate pulmonary nodule) on CT-scan requiring CT-based monitoring rather than biopsy and/or treatment.
  6. Documented history of pulmonary surgery or endobronchial interventional procedures other than biopsy, lavage, or bronchial brushings. These include surgical resection, Video Assisted Thoracic Surgery (VATS), bronchial thermoplasty and coiling, airway stenting or other interventional bronchoscopic procedures.
  7. Pregnant or breastfeeding women and women of child-bearing potential not using adequate contraceptive methods (Subjects must agree to use contraception for 2 months post last dose).

  8. Individuals under investigation for suspicion of lung cancer who are unlikely to receive a definitive tissue diagnosis of lung cancer prior to treatment (e.g. stereotactic ablative radiotherapy without tissue confirmation).

    • Note:

In the case that the participant has taken part in a study with an investigational medicinal product please contact the Owlstone medical monitor for advice.

**Note: Individuals with a confirmed cancer diagnosis ARE eligible (such as a diagnosis of prostate cancer now undergoing hormone therapy). Individual with a previous history of cancer other than lung cancer, including those under active surveillance, ARE eligible. Individuals scheduled to attend a cancer screening program; prostate, breast, lung, colon, ARE eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OWL-EVO1

After confirming full eligibility, individuals will all be administered the OWL-EVO1 probe intravenously.

This includes:

  • Patients diagnosed with histopathologically confirmed lung cancer.
  • Individuals with a CT-proven absence of lung cancer, including those with relevant comorbidities and risk factors such as smoking, COPD, asthma, extrapulmonary malignant tumours, active lung infection/inflammation and other chronic respiratory diseases.
Diagnostic test: OWL-EVO1
EVOC probe
Other Names:
  • OWL-EVO1 Breath Biopsy Test
  • D5-ethyl-βD-glucuronide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: 12 months
The primary endpoint is to assess the diagnostic accuracy of the OWL-EVO1 Breath Biopsy test to differentiate between individuals with lung cancer and contrast groups. This will be reported using a Receiver Operator Characteristic Curve, NPV, PPV, Sensitivity, Specificity & Likelihood Ratio's. Metrics will be reported for overall test performance as well as pre-defined subgroup analyses.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimised test
Time Frame: 12 months
To define a test protocol for breath sampling and the OWL-EVO-1 infusion that achieves the optimal balance between minimising healthcare worker effort, maximising tolerability, and optimising diagnostic accuracy for the intended use setting. This will be in terms of method, timing, posture and duration.
12 months
Safety and tolerability
Time Frame: 12 months
To gain a refined understanding of the safety and tolerability of OWL-EVO1. This will be based on reported Adverse Events associated with probe administration.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Owlstone Ltd

Investigators

  • Principal Investigator: Robert Rintoul, Royal Papworth Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2023

Primary Completion (Estimated)

April 25, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

December 21, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OML-EV2-1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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