Malignant Neoplasm of LungSPUtNIkNCT02013063
Single Pulmonary Nodule Investigation
An observational study of Malignant Neoplasm of Lung, run by University Hospital Southampton NHS Foundation Trust at 9 sites in United Kingdom.
Trial summary
A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN). This is an important group of patients because if it is lung cancer, presentation as a SPN represents early disease, which following surgery has a high 5 year survival rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm of Lung
- How many people
- 375 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Aug 2012to Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospital Chest Clinics PET referal centres
Who may be able to join
- A soft tissue solitary dominant pulmonary nodule of ≥ 8mm and ≤30mm on axial plane
- Measured on lung window using conventional CT scan
- No other ancillary evidence strongly indicative of malignancy (e.g. distant metastases or unequivocal local invasion).
- If clinicians and reporting radiologists believe the patient is being treated as having a single pulmonary nodule and there are other small lesions <4mm that would normally be disregarded, the patient should be included in the trial.
- Nodules already under surveillance can be included provided they have a recent or scheduled FDG-PET/CT18 years of age or over at time of providing consent
- Able and willing to consent to study
Who cannot join
- Pregnancy
- History of malignancy within the past 2 years
- Confirmed aetiology of the nodule at the time of qualifying CT scan - As this is a diagnostic study, should the aetiology of the nodule be confirmed by investigation such as FDG-PET/CT or bronchoscopy prior to consent the patient remains eligible as the intention to include is made on the analysis of the qualifying CT scan.
- Biopsy of nodule prior to DCE-CT scan
- Contra-indication to potential radiotherapy or surgery
- Contra indication to scans (assessed by local procedures)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites, 9 recruiting
- Recruiting
NHS Grampian
Aberdeen, AB25 2ZN
Lesley Gomersall, MD
- Recruiting
Brighton and Sussex University Hospitals Nhs Trust
Brighton, BN2 5BE
Sabina Dr Dizdarevic, MD
- Recruiting
Papworth Hospital Nhs Foundation Trust
Cambridge, CB23 3RE
Nagmi Dr Qureshi, M.B.
- Recruiting
NHS Greater Glasgow and Clyde
Glasgow, G116NT
Sai Han, MBChB
- Recruiting
Leeds Teaching Hospitals Nhs Trust
Leeds, LS9 7TF
Mathhew Dr Callister, BM PhD
- Recruiting
University College London Hospitals Nhs Foundation Trust
London, NW1 2PG
Ashley Dr Groves, MBBS
- Recruiting
University Hospital of South Manchester Nhs Foundation Trust
Manchester, M23 9LT
Philip Dr Crosbie, PhD
- Recruiting
Southampton University Hospitals Nhs Trust
Southampton, Hampshire, SO16 6YD
Anindo Dr Banerjee, PhD
- Recruiting
Western Sussex Hospitals NHS Foundation Trust
Worthing, Sussex, BN112DH
Nick Adams, MD FRCP
About this study
Official title: Accuracy and Cost-Effectiveness of Dynamic Contrast Enhanced Computed Tomography in the Characterisation of Solitary Pulmonary Nodules
A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN). This is an important group of patients because if it is lung cancer, presentation as a SPN represents early disease, which following surgery has a high 5 year survival rate. However as not all SPNs are lung cancer it would be unethical to biopsy every case. Clinical guidelines recommend that SPNs should undergo an initial (FDG)-PET/CT scan, which may give more information about the SPN and may indicate if it is likely to be lung cancer. However in many cases it does not and current practice is to monitor the SPN with a series of CT scans over 2 years to look for changes or growth which may/ but not always indicate lung cancer. If no changes are observed over 2 years the SPN is considered not lung cancer. This is both expensive for the National Health Service (NHS) and worrying for the patient in terms of monitoring CT costs and delayed treatment due to length of time to diagnosis.
This study examines the diagnostic capacity of using a different CT scan. Dynamic Contrast Enhanced -CT(DCE-CT). DCE-CT and FDG-PET/CT scans give different information about the SPN and the investigators will look to see if information from either scan or combined information from both scans may be better in the diagnosis of early stage lung cancer. The investigators will also undertake a review of previous studies that have used these scans and use data from both the review and the trial to look at the cost effectiveness of using DCE-CT in the diagnosis of SPN.
Read more
The trial will recruit 375 people who have a SPN detected by a normal CT scan which requires a FDG-PET/CT scan. In addition they will receive a DCE-CT scan either on the same day or within three weeks of the FDG-PET/CT scan. This is the only extra procedure that will take place to normal NHS care, however we will collect clinical and outcome data over the next two years.
The study is coordinated by Southampton University clinical trials unit. Recruitment between January 2013 - April 2016, from up to 14 UK sites. Data analysis and conclusions are expected by the end of 2018.
The study is funded by the NIHR-HTA
Read the detailed description
Indication: Lung Cancer
Primary Objectives:
- To determine with high precision, the diagnostic performances of DCE-CT and 18FDG-PET/CT in the NHS for the characterisation of solitary pulmonary nodules (SPNs).
- To use decision analytic modelling to assess the likely costs and health outcomes resulting from incorporation of DCE-CT into management strategies for patients with SPNs.
Secondary Objectives:
- To assess, within an NHS setting, the incremental value of incorporating the CT appearances of a SPN into the interpretation of integrated PET/CT examinations.
- To assess whether combining DCE-CT with 18FDG-PET/CT is more accurate and/or cost-effective, in the characterisation of SPNs, than either test used alone or in series.
- To document the nature and incidence of incidental extra-thoracic findings on 18FDG-PET/CT undertaken for the characterisation of SPNs and model their impact on cost-effectiveness.
Rationale:
A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN) on diagnostic imaging tests. This is an important group of patients because presentation as a SPN represents early disease with high 5 year survival rates following surgical resection. However, not all SPNs are due to lung cancer and the accurate characterisation of SPNs for diagnosis of early stage lung cancer is a diagnostic challenge with significant associated health costs.
Widely adopted clinical guidelines for the subsequent investigation of SPNs recommend serial CT scans to look for subsequent growth with biopsy to confirm diagnosis. UK, National Institute for Health and Clinical Excellence (NICE) guidelines recommend 18FDG-PET for the assessment of SPN in cases where a biopsy is not possible or has failed.
DCE-CT and 18FDG-PET scans give different information about the SPN. Information from either scan or combined information from both scans may be better in the diagnosis of early stage lung cancer.
Trial Design: Prospective Observational
Sample size: 375
Non-CTIMP:Non interventional trial
Concomitant Therapy: As per local practice
Primary Trial Endpoints:
Primary outcome measures will include diagnostic test characteristics (sensitivity, specificity, accuracy) for 18FDG-PET/CT and DCE-CT in relation to a subsequent clinical diagnosis of lung cancer. The outcome measures used in the economic model will include accuracy, estimated life expectancy, and quality adjusted life years (QALYs). Costs will be estimated from an NHS perspective. Incremental cost-effectiveness ratios will compare management strategies with DCE-CT to strategies without DCE-CT.
Secondary Trial Endpoints:
Secondary outcome measures will include diagnostic test characteristics for 18FDG-PET/CT with incorporation of CT appearances and combined DCE-CT/18FDG-PET. The incidence of incidental extra-thoracic findings on 18FDG-PET/CT, subsequent investigations and costs will also be determined.
Total Number of Sites: up to 14
- Conditions
- Malignant Neoplasm of Lung
- Keywords
- Single Pulmonary Nodule, SPN, Lung cancer, Diagnostic, Computed Tomography, CT scan, FDG-PET scan, Dynamic CT scan, DCE-CT scan, Dynamic contrast enhanced CT scan, soft tissue solitary dominant, ≥ 8mm and ≤30mm
- Medical subject headings
- Lung Neoplasms, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of DCE-CT scans and FDG-PET scans to diagnose early lung cancer in SPN
Primary outcome measures will include diagnostic test characteristics (sensitivity, specificity, accuracy) for 18FDG-PET/CT and DCE-CT in relation to a subsequent clinical diagnosis of lung cancer.
Measured: 2 years
cost effectiveness of using DCE-CT scans in the diagnosis of early lung cancer in SPN
The outcome measures used in the economic model will include accuracy, estimated life expectancy, and quality adjusted life years (QALYs). Costs will be estimated from an NHS perspective. Incremental cost-effectiveness ratios will compare management strategies with DCE-CT to strategies without DCE-CT.
Measured: 2 years
Secondary outcomes (2)
Effectiveness of DCE-CT scans combined with FDG-PET scans to diagnose early lung cancer in SPN
Diagnostic test characteristics combined DCE-CT/18FDG-PET in relation to a subsequent clinical diagnosis of lung cancer.
Measured: 2 years
Effectiveness of using analysis of the CT image from the FDG-PET/CT in conjunction with data from the FDG incorporation to diagnose early lung cancer in SPN
Diagnostic test characteristics for 18FDG-PET/CT with incorporation of CT appearances in relation to a subsequent clinical diagnosis of lung cancer.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startAug 2012
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of LungStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton, Brighton and Sussex University Hospitals NHS Trust, University College London Hospitals, Oxford University Hospitals NHS Trust, Papworth Hospital NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Manchester University NHS Foundation Trust, East and North Hertfordshire NHS Trust, NHS Grampian, NHS Greater Glasgow and Clyde, Western Sussex Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Steve George, MD,FRCP, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013063
- Sponsor's protocol ID
- RHM RAD0030
- Other IDs
- ISRCTN30784948, project number 09/22/117
- Acronym
- SPUtNIk
- Status last verified
- Oct 2016
- First submitted
- 11 Dec 2013
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: there is no plan to share individual patient data
Publications
Weir-McCall JR, Debruyn E, Harris S, Qureshi NR, Rintoul RC, Gleeson FV, Gilbert FJ; SPUtNIk Investigators. Diagnostic Accuracy of a Convolutional Neural Network Assessment of Solitary Pulmonary Nodules Compared With PET With CT Imaging and Dynamic Contrast-Enhanced CT Imaging Using Unenhanced and Contrast-Enhanced CT Imaging. Chest. 2023 Feb;163(2):444-454. doi: 10.1016/j.chest.2022.08.2227. Epub 2022 Sep 8.
PubMed 36087795Gilbert FJ, Harris S, Miles KA, Weir-McCall JR, Qureshi NR, Rintoul RC, Dizdarevic S, Pike L, Sinclair D, Shah A, Eaton R, Clegg A, Benedetto V, Hill JE, Cook A, Tzelis D, Vale L, Brindle L, Madden J, Cozens K, Little LA, Eichhorst K, Moate P, McClement C, Peebles C, Banerjee A, Han S, Poon FW, Groves AM, Kurban L, Frew AJ, Callister ME, Crosbie P, Gleeson FV, Karunasaagarar K, Kankam O, George S. Dynamic contrast-enhanced CT compared with positron emission tomography CT to characterise solitary pulmonary nodules: the SPUtNIk diagnostic accuracy study and economic modelling. Health Technol Assess. 2022 Mar;26(17):1-180. doi: 10.3310/WCEI8321.
PubMed 35289267Gilbert FJ, Harris S, Miles KA, Weir-McCall JR, Qureshi NR, Rintoul RC, Dizdarevic S, Pike L, Sinclair D, Shah A, Eaton R, Jones J, Clegg A, Benedetto V, Hill J, Cook A, Tzelis D, Vale L, Brindle L, Madden J, Cozens K, Little L, Eichhorst K, Moate P, McClement C, Peebles C, Banerjee A, Han S, Poon FW, Groves AM, Kurban L, Frew A, Callister MEJ, Crosbie PA, Gleeson FV, Karunasaagarar K, Kankam O, George S. Comparative accuracy and cost-effectiveness of dynamic contrast-enhanced CT and positron emission tomography in the characterisation of solitary pulmonary nodules. Thorax. 2022 Oct;77(10):988-996. doi: 10.1136/thoraxjnl-2021-216948. Epub 2021 Dec 9.
PubMed 34887348Weir-McCall JR, Harris S, Miles KA, Qureshi NR, Rintoul RC, Dizdarevic S, Pike L, Cheow HK, Gilbert FJ; SPUtNIk investigators. Impact of solitary pulmonary nodule size on qualitative and quantitative assessment using 18F-fluorodeoxyglucose PET/CT: the SPUTNIK trial. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1560-1569. doi: 10.1007/s00259-020-05089-y. Epub 2020 Nov 1.
PubMed 33130961
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Cost-Effectiveness of Dynamic Contrast Enhanced Computed Tomography in the Characterisation of Solitary Pulmonary Nodules
- ClinicalTrials.gov ID
- NCT02013063
- Acronym / sponsor ID
- SPUtNIk / RHM RAD0030
- Conditions
- Malignant Neoplasm of Lung
- Keywords
- Single Pulmonary Nodule, SPN, Lung cancer, Diagnostic, Computed Tomography, CT scan, FDG-PET scan, Dynamic CT scan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Southampton, Brighton and Sussex University Hospitals NHS Trust, University College London Hospitals, Oxford University Hospitals NHS Trust, Papworth Hospital NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, Manchester University NHS Foundation Trust, East and North Hertfordshire NHS Trust, NHS Grampian, NHS Greater Glasgow and Clyde, Western Sussex Hospitals NHS Trust
- Study start
- Aug 2012
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 17 Dec 2013 (estimated)
- 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.
A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN). This is an important group of patients because if it is lung cancer, presentation as a SPN represents early disease, which following surgery has a high 5 year survival rate. However as not all SPNs are lung cancer it would be unethical to biopsy every case. Clinical guidelines recommend that SPNs should undergo an initial (FDG)-PET/CT scan, which may give more information about the SPN and may indicate if it is likely to be lung cancer. However in many cases it does not and current practice is to monitor the SPN with a series of CT scans over 2 years to look for changes or growth which may/ but not always indicate lung cancer. If no changes are observed over 2 years the SPN is considered not lung cancer. This is both expensive for the National Health Service (NHS) and worrying for the patient in terms of monitoring CT costs and delayed treatment due to length of time to diagnosis.
This study examines the diagnostic capacity of using a different CT scan. Dynamic Contrast Enhanced -CT(DCE-CT). DCE-CT and FDG-PET/CT scans give different information about the SPN and the investigators will look to see if information from either scan or combined information from both scans may be better in the diagnosis of early stage lung cancer. The investigators will also undertake a review of previous studies that have used these scans and use data from both the review and the trial to look at the cost effectiveness of using DCE-CT in the diagnosis of SPN.
The trial will recruit 375 people who have a SPN detected by a normal CT scan which requires a FDG-PET/CT scan. In addition they will receive a DCE-CT scan either on the same day or within three weeks of the FDG-PET/CT scan. This is the only extra procedure that will take place to normal NHS care, however we will collect clinical and outcome data over the next two years.
The study is coordinated by Southampton University clinical trials unit. Recruitment between January 2013 - April 2016, from up to 14 UK sites. Data analysis and conclusions are expected by the end of 2018.
The study is funded by the NIHR-HTA
Detailed description
Indication: Lung Cancer
Primary Objectives:
- To determine with high precision, the diagnostic performances of DCE-CT and 18FDG-PET/CT in the NHS for the characterisation of solitary pulmonary nodules (SPNs).
- To use decision analytic modelling to assess the likely costs and health outcomes resulting from incorporation of DCE-CT into management strategies for patients with SPNs.
Secondary Objectives:
- To assess, within an NHS setting, the incremental value of incorporating the CT appearances of a SPN into the interpretation of integrated PET/CT examinations.
- To assess whether combining DCE-CT with 18FDG-PET/CT is more accurate and/or cost-effective, in the characterisation of SPNs, than either test used alone or in series.
- To document the nature and incidence of incidental extra-thoracic findings on 18FDG-PET/CT undertaken for the characterisation of SPNs and model their impact on cost-effectiveness.
Rationale:
A small proportion of patients with lung cancer present with a solitary pulmonary nodule (SPN) on diagnostic imaging tests. This is an important group of patients because presentation as a SPN represents early disease with high 5 year survival rates following surgical resection. However, not all SPNs are due to lung cancer and the accurate characterisation of SPNs for diagnosis of early stage lung cancer is a diagnostic challenge with significant associated health costs.
Widely adopted clinical guidelines for the subsequent investigation of SPNs recommend serial CT scans to look for subsequent growth with biopsy to confirm diagnosis. UK, National Institute for Health and Clinical Excellence (NICE) guidelines recommend 18FDG-PET for the assessment of SPN in cases where a biopsy is not possible or has failed.
DCE-CT and 18FDG-PET scans give different information about the SPN. Information from either scan or combined information from both scans may be better in the diagnosis of early stage lung cancer.
Trial Design: Prospective Observational
Sample size: 375
Non-CTIMP:Non interventional trial
Concomitant Therapy: As per local practice
Primary Trial Endpoints:
Primary outcome measures will include diagnostic test characteristics (sensitivity, specificity, accuracy) for 18FDG-PET/CT and DCE-CT in relation to a subsequent clinical diagnosis of lung cancer. The outcome measures used in the economic model will include accuracy, estimated life expectancy, and quality adjusted life years (QALYs). Costs will be estimated from an NHS perspective. Incremental cost-effectiveness ratios will compare management strategies with DCE-CT to strategies without DCE-CT.
Secondary Trial Endpoints:
Secondary outcome measures will include diagnostic test characteristics for 18FDG-PET/CT with incorporation of CT appearances and combined DCE-CT/18FDG-PET. The incidence of incidental extra-thoracic findings on 18FDG-PET/CT, subsequent investigations and costs will also be determined.
Total Number of Sites: up to 14
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital Chest Clinics PET referal centres
Key inclusion criteria (6 listed)
- A soft tissue solitary dominant pulmonary nodule of ≥ 8mm and ≤30mm on axial plane
- If clinicians and reporting radiologists believe the patient is being treated as having a single pulmonary nodule and there are other small lesions <4mm that would normally be disregarded, the patient should be included in the trial.
- Nodules already under surveillance can be included provided they have a recent or scheduled FDG-PET/CT18 years of age or over at time of providing consent
- Able and willing to consent to study
Key exclusion criteria (6 listed)
- Pregnancy
- History of malignancy within the past 2 years
- Confirmed aetiology of the nodule at the time of qualifying CT scan - As this is a diagnostic study, should the aetiology of the nodule be confirmed by investigation such as FDG-PET/CT or bronchoscopy prior to consent the patient remains eligible as the intention to include is made on the analysis of the qualifying CT scan.
- Biopsy of nodule prior to DCE-CT scan
- Contra-indication to potential radiotherapy or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effectiveness of DCE-CT scans and FDG-PET scans to diagnose early lung cancer in SPN
Time frame: 2 years
Primary outcome measures will include diagnostic test characteristics (sensitivity, specificity, accuracy) for 18FDG-PET/CT and DCE-CT in relation to a subsequent clinical diagnosis of lung cancer.
cost effectiveness of using DCE-CT scans in the diagnosis of early lung cancer in SPN
Time frame: 2 years
The outcome measures used in the economic model will include accuracy, estimated life expectancy, and quality adjusted life years (QALYs). Costs will be estimated from an NHS perspective. Incremental cost-effectiveness ratios will compare management strategies with DCE-CT to strategies without DCE-CT.
2 secondary outcomes
Effectiveness of DCE-CT scans combined with FDG-PET scans to diagnose early lung cancer in SPN
Time frame: 2 years
Effectiveness of using analysis of the CT image from the FDG-PET/CT in conjunction with data from the FDG incorporation to diagnose early lung cancer in SPN
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Derived from this study: PubMed 36087795Weir-McCall JR, Debruyn E, Harris S, Qureshi NR, Rintoul RC, Gleeson FV, Gilbert FJ; SPUtNIk Investigators. Diagnostic Accuracy of a Convolutional Neural Network Assessment of Solitary Pulmonary Nodules Compared With PET With CT Imaging and Dynamic Contrast-Enhanced CT Imaging Using Unenhanced and Contrast-Enhanced CT Imaging. Chest. 2023 Feb;163(2):444-454. doi: 10.1016/j.chest.2022.08.2227. Epub 2022 Sep 8.
- Derived from this study: PubMed 35289267Gilbert FJ, Harris S, Miles KA, Weir-McCall JR, Qureshi NR, Rintoul RC, Dizdarevic S, Pike L, Sinclair D, Shah A, Eaton R, Clegg A, Benedetto V, Hill JE, Cook A, Tzelis D, Vale L, Brindle L, Madden J, Cozens K, Little LA, Eichhorst K, Moate P, McClement C, Peebles C, Banerjee A, Han S, Poon FW, Groves AM, Kurban L, Frew AJ, Callister ME, Crosbie P, Gleeson FV, Karunasaagarar K, Kankam O, George S. Dynamic contrast-enhanced CT compared with positron emission tomography CT to characterise solitary pulmonary nodules: the SPUtNIk diagnostic accuracy study and economic modelling. Health Technol Assess. 2022 Mar;26(17):1-180. doi: 10.3310/WCEI8321.
- Derived from this study: PubMed 34887348Gilbert FJ, Harris S, Miles KA, Weir-McCall JR, Qureshi NR, Rintoul RC, Dizdarevic S, Pike L, Sinclair D, Shah A, Eaton R, Jones J, Clegg A, Benedetto V, Hill J, Cook A, Tzelis D, Vale L, Brindle L, Madden J, Cozens K, Little L, Eichhorst K, Moate P, McClement C, Peebles C, Banerjee A, Han S, Poon FW, Groves AM, Kurban L, Frew A, Callister MEJ, Crosbie PA, Gleeson FV, Karunasaagarar K, Kankam O, George S. Comparative accuracy and cost-effectiveness of dynamic contrast-enhanced CT and positron emission tomography in the characterisation of solitary pulmonary nodules. Thorax. 2022 Oct;77(10):988-996. doi: 10.1136/thoraxjnl-2021-216948. Epub 2021 Dec 9.
- Derived from this study: PubMed 33130961Weir-McCall JR, Harris S, Miles KA, Qureshi NR, Rintoul RC, Dizdarevic S, Pike L, Cheow HK, Gilbert FJ; SPUtNIk investigators. Impact of solitary pulmonary nodule size on qualitative and quantitative assessment using 18F-fluorodeoxyglucose PET/CT: the SPUTNIK trial. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1560-1569. doi: 10.1007/s00259-020-05089-y. Epub 2020 Nov 1.
- Individual participant dataSharing planned: No. there is no plan to share individual patient data
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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.
Steve George, MD,FRCP principal investigator
University of Southampton
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm of Lung, run by University Hospital Southampton NHS Foundation Trust at 9 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 6 inclusion and 6 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 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Jackie Madden, PhD (00442381203833, jm24@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of DCE-CT scans and FDG-PET scans to diagnose early lung cancer in SPN (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02013063, which also lists 4 linked publications.
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 18 Oct 2016; AzTrials last refreshed its copy on 30 Oct 2026.