Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
375 participants
Study Classification
OBSERVATIONAL
Study Start Date
2012-08-31
Study Completion Date
2018-10-31
Brief Summary
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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
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
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Detailed Description
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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
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
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Malignant Neoplasm of Lung
Study Design
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Observational Model Type
CASE_ONLY
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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)
* 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)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Southampton
OTHER
Sponsor Role
collaborator
Brighton and Sussex University Hospitals NHS Trust
OTHER
Sponsor Role
collaborator
University College London Hospitals
OTHER
Sponsor Role
collaborator
Oxford University Hospitals NHS Trust
OTHER
Sponsor Role
collaborator
Papworth Hospital NHS Foundation Trust
OTHER_GOV
Sponsor Role
collaborator
The Leeds Teaching Hospitals NHS Trust
OTHER
Sponsor Role
collaborator
Manchester University NHS Foundation Trust
OTHER_GOV
Sponsor Role
collaborator
East and North Hertfordshire NHS Trust
OTHER_GOV
Sponsor Role
collaborator
NHS Grampian
OTHER_GOV
Sponsor Role
collaborator
NHS Greater Glasgow and Clyde
OTHER
Sponsor Role
collaborator
Western Sussex Hospitals NHS Trust
OTHER
Sponsor Role
collaborator
University Hospital Southampton NHS Foundation Trust
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Steve George, MD,FRCP
Role: PRINCIPAL_INVESTIGATOR
University of Southampton
Locations
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Southampton University Hospitals Nhs Trust
Southampton, Hampshire, United Kingdom
Site Status
RECRUITING
Western Sussex Hospitals NHS Foundation Trust
Worthing, Sussex, United Kingdom
Site Status
RECRUITING
NHS Grampian
Aberdeen, , United Kingdom
Site Status
RECRUITING
Brighton and Sussex University Hospitals Nhs Trust
Brighton, , United Kingdom
Site Status
RECRUITING
Papworth Hospital Nhs Foundation Trust
Cambridge, , United Kingdom
Site Status
RECRUITING
NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Site Status
RECRUITING
Leeds Teaching Hospitals Nhs Trust
Leeds, , United Kingdom
Site Status
RECRUITING
University College London Hospitals Nhs Foundation Trust
London, , United Kingdom
Site Status
RECRUITING
University Hospital of South Manchester Nhs Foundation Trust
Manchester, , United Kingdom
Site Status
RECRUITING
Countries
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United Kingdom
Central Contacts
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Facility Contacts
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Nick Adams, MD FRCP
Role: primary
References
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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.
Reference Type
DERIVED
Gilbert 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.
Reference Type
DERIVED
Gilbert 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.
Reference Type
DERIVED
Weir-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.
Reference Type
DERIVED
Other Identifiers
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ISRCTN30784948
Identifier Type: OTHER
Identifier Source: secondary_id
project number 09/22/117
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RHM RAD0030
Identifier Type: -
Identifier Source: org_study_id
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