Status:
RECRUITING
Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe (Evolution Phase 2)
Lead Sponsor:
Owlstone Ltd
Conditions:
Lung Cancer
Eligibility:
All Genders
45-85 years
Phase:
PHASE2
Brief Summary
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 con...
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 cleav...
Eligibility Criteria
Inclusion
- 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
- (Anticipated) inability to complete the breath sampling procedure (e.g., inability to maintain adequate ventilation unaided or claustrophobia).
- Potential subjects who in the opinion of the investigator lack mental capacity.
- 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.\*
- Individuals under diagnostic investigation for a potential malignancy other than lung cancer that has not yet reached a conclusive diagnosis\*\*.
- Individuals with an inconclusive lung abnormality (indeterminate pulmonary nodule) on CT-scan requiring CT-based monitoring rather than biopsy and/or treatment.
- 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.
- 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).
- 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.
Key Trial Info
Start Date :
October 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2025
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06193239
Start Date
October 5 2023
End Date
April 30 2025
Last Update
October 15 2024
Active Locations (9)
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1
Thomayer Hospital
Prague, Prague, Czechia, 140 59
2
National Koranyi Institute for Pulmonology
Budapest, Budapest, Hungary, H-1121
3
Department of Pulmonology, University of Debrecen
Debrecen, Debrecen, Hungary, H-4032
4
Royal Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0AY