Trial Title:
Diagnostic Accuracy Study for OWL-EVO1 As a Lung Cancer EVOC® Probe (Evolution Phase 2)
NCT ID:
NCT06193239
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung Cancer
Diagnostic Test
Diagnostic Breath test
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Participants with and without suspicion of having lung cancer will all receive the same
IMP
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
OWL-EVO1
Description:
EVOC probe
Arm group label:
OWL-EVO1
Other name:
OWL-EVO1 Breath Biopsy Test
Other name:
D5-ethyl-βD-glucuronide
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 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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
45 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Thomayer Hospital
Address:
City:
Prague
Zip:
140 59
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Jiri Skopek
Email:
jiri.skopek1@ftn.cz
Contact backup:
Last name:
Dr Marie Drosslerova
Facility:
Name:
National Koranyi Institute for Pulmonology
Address:
City:
Budapest
Zip:
H-1121
Country:
Hungary
Status:
Not yet recruiting
Contact:
Last name:
Karolina Argay
Phone:
36 20 5797 097
Email:
argay.karolina@koranyi.hu
Contact backup:
Last name:
Dr Ildiko Horvath
Facility:
Name:
Department of Pulmonology, University of Debrecen
Address:
City:
Debrecen
Zip:
H-4032
Country:
Hungary
Status:
Recruiting
Contact:
Last name:
Dr Ildiko Horvath
Facility:
Name:
Royal Papworth Hospital NHS Foundation Trust
Address:
City:
Cambridge
Zip:
CB2 0AY
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Amanda Stone
Phone:
01223 638000
Email:
Amanda.Stone5@nhs.net
Contact backup:
Last name:
Zoe Armstrong
Phone:
01223 638000
Email:
zoe.armstrong12@nhs.net
Contact backup:
Last name:
Dr Laura Succony
Facility:
Name:
Wythenshawe Hospital
Address:
City:
Manchester
Zip:
M23 9LT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Shilpa Pushpan
Phone:
0161 291 5388
Email:
Shilpa.Pushpan@mft.nhs.uk
Contact backup:
Last name:
Zara Gatt
Phone:
0161 291 5388
Email:
Zara.Gatt@mft.nhs.uk
Contact backup:
Last name:
Professor Philip Crosbie
Facility:
Name:
Glenfield Hospital
Address:
City:
Leicester
Zip:
LE3 9QP
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Rebecca Boyles
Email:
Rebecca.boyles@uhl-tr.nhs.uk
Contact backup:
Last name:
Dr Edward Caruana
Facility:
Name:
Quadram Institute
Address:
City:
Norwich
Zip:
NR4 7UQ
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Lisa Hudig
Phone:
01603 286 366
Email:
lisa.hudig@nnuh.nhs.uk
Contact backup:
Last name:
Bethany Bridgwood
Phone:
01603 286366
Phone ext:
2366
Email:
Bethany.Bridgwood@nnuh.nhs.uk
Contact backup:
Last name:
Professor Eleanor Mishra
Facility:
Name:
Barts Health NHS Trust
Address:
City:
London
Zip:
E1 1FR
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Maria Lapuente
Email:
m.lapuente@nhs.net
Contact backup:
Last name:
Dr William Ricketts
Facility:
Name:
Imperial Centre for Translational and Experimental Medicine, Imperial College
Address:
City:
London
Zip:
W12 0HS
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Lisa Hurley
Phone:
020 3313 6197
Email:
lisa.hurley2@nhs.net
Contact backup:
Last name:
Asha Vikraman
Email:
asha.vikraman@nhs.net
Contact backup:
Last name:
Dr Susannah Bloch
Start date:
October 5, 2023
Completion date:
April 30, 2025
Lead sponsor:
Agency:
Owlstone Ltd
Agency class:
Industry
Source:
Owlstone Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06193239
