Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe (Evolution Phase 2)
NCT ID: NCT06193239
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
350 participants
INTERVENTIONAL
2023-10-05
2025-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
OWL-EVO1
EVOC probe
Interventions
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OWL-EVO1
EVOC probe
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to provide informed consent.
* BMI 16 - \<40.
* Receiving a CT including the thoracic region, within the last 6 months.
Exclusion Criteria
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.
45 Years
85 Years
ALL
No
Sponsors
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Owlstone Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Rintoul
Role: PRINCIPAL_INVESTIGATOR
Royal Papworth Hospital NHS Foundation Trust
Locations
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Thomayer Hospital
Prague, Prague, Czechia
National Koranyi Institute for Pulmonology
Budapest, Budapest, Hungary
Department of Pulmonology, University of Debrecen
Debrecen, Debrecen, Hungary
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Wythenshawe Hospital
Manchester, Greater Manchester, United Kingdom
Glenfield Hospital
Leicester, Leicestershire, United Kingdom
Barts Health NHS Trust
London, London, United Kingdom
Imperial Centre for Translational and Experimental Medicine, Imperial College
London, London, United Kingdom
Quadram Institute
Norwich, Norfolk, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Dr Marie Drosslerova
Role: backup
Dr Ildiko Horvath
Role: backup
Dr Ildiko Horvath
Role: primary
Dr Laura Succony
Role: backup
Professor Philip Crosbie
Role: backup
Dr Edward Caruana
Role: backup
Dr William Ricketts
Role: backup
Dr Susannah Bloch
Role: backup
Professor Eleanor Mishra
Role: backup
Other Identifiers
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OML-EV2-1.0
Identifier Type: -
Identifier Source: org_study_id
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