Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT03312712
Eligibility Criteria:
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 α1-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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT03312712
Study Brief:
Protocol Section:
NCT03312712