Sarcoidosis Clinical Trial
— VERIFYOfficial title:
Validation of the Analysis Methodology Behind the Use of Quantitative 2-deoxy-2-[Fluorine-18] Fluoro-D-glucose (18F-FDG) Positron Emission Tomography/Computed Tomography (PET/CT) to Assess Lung Inflammation
NCT number | NCT03312712 |
Other study ID # | VERIFY |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 23, 2018 |
Est. completion date | January 2022 |
The purpose of this study is to validate the method of analysing Positron Emission Tomography
(PET) images to assess lung inflammation. Development of novel therapeutic drugs requires a
biomarker which is sensitive to the underlying disease and can respond to therapeutic
interventions. PET is a potential imaging biomarker which can target molecular and cellular
processes. There is currently no standardised method of analysing PET lung data and a lack of
validation for the existing techniques.
This study is divided in to two parts. Part A aims to determine the best method to perform
18F-FDG PET/CT lung analysis and how it correlates with cell counts from bronchoalveolar
lavage (BAL) samples taken from participants with active pulmonary sarcoidosis.
Part B will compare imaging data from healthy volunteers who have either undergone a
Lipopolysaccharide (LPS) challenge (whereby the lung is temporarily inflamed) or saline
equivalent to determine whether lung inflammation can be detected by 18F-FDG PET/CT. No
medications will be given and patients will not be asked to stop or change existing
medication.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | January 2022 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years and older |
Eligibility |
For patients with sarcoidosis: Inclusion Criteria: - Suspected pulmonary sarcoidosis (as determined by referring physician) - Requires bronchoscopy, EBUS and BAL (as determined by ILD team at Royal Papworth or Addenbrooke's Hospitals). - Male or female = 30 years with a BMI of 17-35kg/m2 - Consents to additional bronchoscopic evaluation during NHS mandated bronchoscopy, EBUS and BAL. Exclusion Criteria: - Inability to provide Informed Consent. - A cardiovascular event in the last 6 months (i.e. acute coronary syndrome, unstable angina, CABG, PCI, stroke, MI, carotid endarterectomy). - Patients with known clinically significant pulmonary diagnoses of COPD, lung fibrosis, interstitial lung disease, or a1-antitrypsin deficiency. - Active smoking during the last 5 years. - Patients with known chronic infections such as HIV or known active tuberculosis. - Patients with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic inflammation (e.g. Inflammatory Bowel Disease). - Known diabetes mellitus or known impaired glucose tolerance - Participation in a previous research trial in the last three years which involved exposure to significant ionising radiation (i.e. cumulative research radiation dose >10 mSv) - Pregnancy - Women of childbearing potential [i.e. either postmenopausal or documented hysterectomy and/or bilateral oophorectomy - tubal ligation is not sufficient]. - Use of systemic steroids (oral or intravenous) at a dose > 10mg od of prednisolone or equivalent and/or antibiotics 4 weeks prior to PET/CT scan - Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern For healthy volunteers: Inclusion criteria: - Age/gender-matched group (Part A only): Male or female = 30 years with a BMI of 17-35kg/m2 inclusive - LPS/saline challenge group (Part B only): Male or female = 50 years with a BMI of 17-35kg/m2 inclusive - No smoking history - Normal predicted spirometry values: FEV1/FVC > 0.7 and FEV1 > 80% predicted - Healthy as determined by clinical history & examination by the investigator Exclusion criteria: - Inability to provide informed consent - Pregnancy - Patients with known chronic inflammation conditions such as rheumatoid arthritis, connective tissue disorders and inflammatory bowel disease - A significant cardiovascular event in the last 6 months - Insulin dependent diabetes mellitus or known impaired glucose tolerance - Participation in previous research trial in the last three years which involves exposure to significant ionising radiation (cumulative dose >10mSv) - Use of systemic steroids (oral or intravenous) at a dose > 10mg od of prednisolone or equivalent and/or antibiotics 4 weeks prior to PET/CT scan - Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern - Women of childbearing potential - Patients with known chronic infections such as HIV or known active tuberculosis. - Active smoking history (defined as > than 1 cigarette per day on a regular basis) over lifetime - Known lung and/or respiratory disease or associated symptoms (e.g. dyspnoea, wheeze) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge University Hospitals NHS Foundation Trust | Cambridge | |
United Kingdom | Royal Papworth Hospital NHS Foundation Trust | Papworth Everard |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust | GlaxoSmithKline |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Validation of 18F-FDG methodology used to assess lung inflammation in participants with sarcoidosis | 18F-FDG will be assessed using Patlak analysis and a compartmental model. This will be validated against histological samples from lung biopsies taken as part of the patient's standard clinical care prior to enrolling on to this study, and the inflammatory cell counts and densities (principally of macrophages and neutrophils) from BAL fluid in sarcoidosis patients. | Up to 4 weeks | |
Secondary | Pulmonary function tests | Spirometry (FVC and FEV1) | Screening Visit (V1) | |
Secondary | Pulmonary function tests | Gas transfer (TLCO measurement). Healthy volunteers will be asked to blow hard and fast into a mouthpiece for as long as possible and hold their breath for about 10 seconds. | Screening Visit (V1) | |
Secondary | Plasma biomarkers of inflammation | CRP levels (mg/L) | Up to 4 weeks | |
Secondary | Plasma biomarkers of inflammation | Fibrinogen levels (mg/dL) | Up to 4 weeks | |
Secondary | Leukocyte count and activity from BAL fluid samples | Immunohistochemical staining where necessary (cell count) | Up to 6 weeks |
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