Lung InflammationVERIFYNCT03312712
Validation of the Analysis Methodology Behind the Use of Quantitative 18F-FDG PET/CT to Assess Lung Inflammation
An observational study of Lung Inflammation and Sarcoidosis, run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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 which is sensitive to the underlying disease and can respond to therapeutic interventions. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Inflammation, Sarcoidosis
- What is being tested?
- PET/CT scan, LPS Challenge and Saline Challenge
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 36 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 23 Jan 2018to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cohort 1: Participants with suspected pulmonary sarcoidosis Cohort 2: Healthy volunteers who are non-smokers, age and gender matched, where possible, to cohort 1 participants
Who may be able to join
- 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.
- 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
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- 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
Who cannot join
- 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).
Show all 25Show fewer
- 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:
- 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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Laurence Vass, MSc
Joseph Cheriyan, MBCHB, MA, FRCP
- Recruiting
Royal Papworth Hospital NHS Foundation Trust
Papworth Everard, CB23 3RE
Muhunthan Thillai, BA, PhD, MRCP
Muhunthan Thillai, BA, PhD, MRCP
About this study
Official 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
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.
Read the 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. Imaging offers a method of assessing lung inflammation which is non-invasive and may help facilitate the development of new therapeutic drugs. Positron Emission Tomography (PET) is a sensitive imaging modality that uses radioactive material to highlight areas of disease. 18F-FDG is the most common radioactive tracer; it accumulates in cells with an increased metabolic rate. Previous studies have shown that inflammatory cells have an increased metabolic rate, thus PET imaging could highlight inflammation. 18F-FDG PET has been used in many studies exploring lung diseases; the concentration of tracer is thought to relate to the severity of inflammation.
There is currently no standardised method to analyse FDG-PET scans to assess the concentration of tracer in the lung (and therefore inflammation). A major challenge is providing corrections to ensure that the image only represents tracer in the lung tissue. Such corrections are non-trivial and affect how images are interpreted. A robust validation is needed to ensure that the analysis methods used in FDG-PET images truly represent the degree of lung inflammation.
Part A of this study aims to validate and compare the different analysis methods. Pulmonary sarcoidosis is a disease characterised by widespread lung inflammation. In Part A of the study the investigators will recruit patients with this condition, as well as age and gender matched (wherever possible) healthy volunteers. All Part A participants will receive one dynamic 18F-FDG PET/CT scan. The investigators will assess the uptake of 18FDG from PET images from patients with sarcoidosis versus those taken from healthy volunteers to validate and assess the reliability of the analysis method.
For Part B of the study the investigators will recruit healthy volunteers aged 50 or more. If sarcoidosis patients in Part A are 50 years old or more, the age-matched HV will be recruited in to Part B instead, thus potentially minimising the number of HVs that might need to be recruited in to Part A of the study.
The aims of this research study are:
- To compare FDG-PET derived tissue inflammation measures against measures of inflammation from BAL samples. ii) To compare different models of 18F-FDG lung analysis in patients with pulmonary sarcoidosis. iii) To identify whether FDG PET is sensitive enough to detect a change in inflammation induced in healthy volunteers.
- Conditions
- Lung Inflammation, Sarcoidosis
- Being tested
- PET/CT scan, LPS Challenge, Saline Challenge, Blood and urine sampling
- Keywords
- FDG, PET, CT, Sarcoidosis
- Medical subject headings
- Pneumonia, Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT scanRadiation
PET/CT will be performed at Cambridge University Hospital's PET-CT unit, Cambridge.
Participants in Part A of the study (sarcoidosis and HVs) will receive one PET/CT scan. A Cine-CT scan will be performed immediately prior to the 18F-FDG PET/CT scan. Settings for the CT scans will be determined by clinical protocols, radiation dose will be kept as low as reasonably practicable (ALARP) consistent with UK legislation.
After 6 hours of fasting and if blood glucose concentration is ≤11mmol/L participants will proceed to undergo an 18FDG PET/CT scan.
18F-FDG will be administered intravenously at a dose of approximately 200 MBq.
Positron emission scanning will involve a 60-minute dynamic acquisition from the lungs.
LPS ChallengeOther
In Part B, eight healthy volunteers will undergo an LPS challenge whereby each participant is injected with the challenge agent, Lipopolysaccharide (LPS), to invoke temporary mild lung inflammation. Each participant will have a PET/CT scan before and after the administration of LPS and the images will be assessed to determine whether these methods are able to detect true lung inflammation.
Saline ChallengeOther
In Part B, four healthy volunteers will undergo a saline challenge as outlined above for the LPS challenge. Pre- and post-challenge scans will provide control data for the study.
Blood and urine samplingDiagnostic test
For women whose post-menopausal status and/or pregnancy status is uncertain at screening, a blood sample will be collected to test for pregnancy and menopausal status (hormone profiling) before enrolling them on to the study. If pregnancy status is still uncertain at study visits, participants will have a urine pregnancy test before undergoing any PET/CT scans to ensure it is safe for them to continue in the study.
| Study group | Role | What they receive |
|---|---|---|
| Participants with sarcoidosis | * Bronchoscopy, BAL collection, and PFTs* [SoC] *if required
* Screening, research and safety bloods
* Dynamic 18F-FDG PET/CT scan Receives: Radiation: PET/CT scan; Diagnostic Test: Blood and urine sampling | |
| Healthy volunteers | Part A:
* PFTs
* Screening, research and safety bloods
* Dynamic 18F-FDG PET/CT scan
Part B:
* PFTs
* Screening, research and safety bloods
* Baseline and post challenge Dynamic 18F-FDG PET/CT scans
* LPS/saline challenge Receives: Radiation: PET/CT scan; Other: LPS Challenge; Other: Saline Challenge; Diagnostic Test: Blood and urine sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 4 weeks
Secondary outcomes (5)
Pulmonary function tests
Spirometry (FVC and FEV1)
Measured: Screening Visit (V1)
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.
Measured: Screening Visit (V1)
Plasma biomarkers of inflammation
CRP levels (mg/L)
Measured: Up to 4 weeks
Plasma biomarkers of inflammation
Fibrinogen levels (mg/dL)
Measured: Up to 4 weeks
Leukocyte count and activity from BAL fluid samples
Immunohistochemical staining where necessary (cell count)
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start23 Jan 2018
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Joseph Cheriyan, MD, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Joseph Cheriyan, MBChB, MA, FRCP, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312712
- Sponsor's protocol ID
- VERIFY
- Acronym
- VERIFY
- Status last verified
- Jan 2020
- First submitted
- 9 Oct 2017
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03312712
- Acronym / sponsor ID
- VERIFY / VERIFY
- Conditions
- Lung Inflammation, Sarcoidosis
- Keywords
- FDG, PET, CT, Sarcoidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. Imaging offers a method of assessing lung inflammation which is non-invasive and may help facilitate the development of new therapeutic drugs. Positron Emission Tomography (PET) is a sensitive imaging modality that uses radioactive material to highlight areas of disease. 18F-FDG is the most common radioactive tracer; it accumulates in cells with an increased metabolic rate. Previous studies have shown that inflammatory cells have an increased metabolic rate, thus PET imaging could highlight inflammation. 18F-FDG PET has been used in many studies exploring lung diseases; the concentration of tracer is thought to relate to the severity of inflammation.
There is currently no standardised method to analyse FDG-PET scans to assess the concentration of tracer in the lung (and therefore inflammation). A major challenge is providing corrections to ensure that the image only represents tracer in the lung tissue. Such corrections are non-trivial and affect how images are interpreted. A robust validation is needed to ensure that the analysis methods used in FDG-PET images truly represent the degree of lung inflammation.
Part A of this study aims to validate and compare the different analysis methods. Pulmonary sarcoidosis is a disease characterised by widespread lung inflammation. In Part A of the study the investigators will recruit patients with this condition, as well as age and gender matched (wherever possible) healthy volunteers. All Part A participants will receive one dynamic 18F-FDG PET/CT scan. The investigators will assess the uptake of 18FDG from PET images from patients with sarcoidosis versus those taken from healthy volunteers to validate and assess the reliability of the analysis method.
For Part B of the study the investigators will recruit healthy volunteers aged 50 or more. If sarcoidosis patients in Part A are 50 years old or more, the age-matched HV will be recruited in to Part B instead, thus potentially minimising the number of HVs that might need to be recruited in to Part A of the study.
The aims of this research study are:
- To compare FDG-PET derived tissue inflammation measures against measures of inflammation from BAL samples. ii) To compare different models of 18F-FDG lung analysis in patients with pulmonary sarcoidosis. iii) To identify whether FDG PET is sensitive enough to detect a change in inflammation induced in healthy volunteers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with sarcoidosis | – | Radiation: PET/CT scan, Diagnostic Test: Blood and urine sampling* Bronchoscopy, BAL collection, and PFTs* [SoC] *if required * Screening, research and safety bloods * Dynamic 18F-FDG PET/CT scan |
| Healthy volunteers | – | Radiation: PET/CT scan, Other: LPS Challenge, Other: Saline Challenge, Diagnostic Test: Blood and urine samplingPart A: * PFTs * Screening, research and safety bloods * Dynamic 18F-FDG PET/CT scan Part B: * PFTs * Screening, research and safety bloods * Baseline and post challenge Dynamic 18F-FDG PET/CT scans * LPS/saline challenge |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort 1: Participants with suspected pulmonary sarcoidosis Cohort 2: Healthy volunteers who are non-smokers, age and gender matched, where possible, to cohort 1 participants
Key inclusion criteria (9 listed)
- 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.
- Age/gender-matched group (Part A only): Male or female ≥ 30 years with a BMI of 17-35kg/m2 inclusive
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT scanPET/CT will be performed at Cambridge University Hospital's PET-CT unit, Cambridge. Participants in Part A of the study (sarcoidosis and HVs) will receive one PET/CT scan. A Cine-CT scan will be performed immediately prior to the 18F-FDG PET/CT scan. Settings for the CT scans will be determined by clinical protocols, radiation dose will be kept as low as reasonably practicable (ALARP) consistent with UK legislation. After 6 hours of fasting and if blood glucose concentration is ≤11mmol/L participants will proceed to undergo an 18FDG PET/CT scan. 18F-FDG will be administered intravenously at a dose of approximately 200 MBq. Positron emission scanning will involve a 60-minute dynamic acquisition from the lungs. | Radiation | Healthy volunteers, Participants with sarcoidosis |
| LPS ChallengeIn Part B, eight healthy volunteers will undergo an LPS challenge whereby each participant is injected with the challenge agent, Lipopolysaccharide (LPS), to invoke temporary mild lung inflammation. Each participant will have a PET/CT scan before and after the administration of LPS and the images will be assessed to determine whether these methods are able to detect true lung inflammation. | Other | Healthy volunteers |
| Saline ChallengeIn Part B, four healthy volunteers will undergo a saline challenge as outlined above for the LPS challenge. Pre- and post-challenge scans will provide control data for the study. | Other | Healthy volunteers |
| Blood and urine samplingFor women whose post-menopausal status and/or pregnancy status is uncertain at screening, a blood sample will be collected to test for pregnancy and menopausal status (hormone profiling) before enrolling them on to the study. If pregnancy status is still uncertain at study visits, participants will have a urine pregnancy test before undergoing any PET/CT scans to ensure it is safe for them to continue in the study. | Diagnostic test | Healthy volunteers, Participants with sarcoidosis |
Primary outcome
Validation of 18F-FDG methodology used to assess lung inflammation in participants with sarcoidosis
Time frame: Up to 4 weeks
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.
5 secondary outcomes
Pulmonary function tests
Time frame: Screening Visit (V1)
Pulmonary function tests
Time frame: Screening Visit (V1)
Plasma biomarkers of inflammation
Time frame: Up to 4 weeks
Plasma biomarkers of inflammation
Time frame: Up to 4 weeks
Leukocyte count and activity from BAL fluid samples
Time frame: Up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Cheriyan, MBChB, MA, FRCP principal investigator
Cambridge University Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Inflammation and Sarcoidosis, run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurence Vass (01223 216895, ldv22@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of 18F-FDG methodology used to assess lung inflammation in participants with sarcoidosis (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.