Status:
UNKNOWN
Validation of the Analysis Methodology Behind the Use of Quantitative 18F-FDG PET/CT to Assess Lung Inflammation
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Lung Inflammation
Sarcoidosis
Eligibility:
All Genders
30+ years
Brief Summary
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 whic...
Detailed Description
Inflammation plays an important role in a myriad of human diseases. Interstitial Lung Diseases (ILDs) are characterised by widespread inflammation and represent a major burden to the health sector. Im...
Eligibility Criteria
Inclusion
- For patients with sarcoidosis:
- 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
- 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)
Key Trial Info
Start Date :
January 23 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03312712
Start Date
January 23 2018
End Date
January 1 2022
Last Update
January 9 2020
Active Locations (2)
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1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
2
Royal Papworth Hospital NHS Foundation Trust
Papworth Everard, United Kingdom, CB23 3RE