Ignite Creation Date:
2024-05-06 @ 2:20 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02013063
Status:
UNKNOWN
Last Update Posted:
2016-10-18
First Post:
2013-12-11
Brief Title:
Single Pulmonary Nodule Investigation
Sponsor:
University Hospital Southampton NHS Foundation Trust
Organization:
University Hospital Southampton NHS Foundation Trust
Study Overview
Official Title:
Accuracy and Cost-Effectiveness of Dynamic Contrast Enhanced Computed Tomography in the Characterisation of Solitary Pulmonary Nodules
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPUtNIk
Brief 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 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-PETCT 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 -CTDCE-CT DCE-CT and FDG-PETCT 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-PETCT scan In addition they will receive a DCE-CT scan either on the same day or within three weeks of the FDG-PETCT 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 -CTDCE-CT DCE-CT and FDG-PETCT 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-PETCT scan In addition they will receive a DCE-CT scan either on the same day or within three weeks of the FDG-PETCT 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-PETCT 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 PETCT examinations
To assess whether combining DCE-CT with 18FDG-PETCT is more accurate andor 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-PETCT 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-CTIMPNon interventional trial
Concomitant Therapy As per local practice
Primary Trial Endpoints
Primary outcome measures will include diagnostic test characteristics sensitivity specificity accuracy for 18FDG-PETCT 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-PETCT with incorporation of CT appearances and combined DCE-CT18FDG-PET The incidence of incidental extra-thoracic findings on 18FDG-PETCT 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-PETCT 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 PETCT examinations
To assess whether combining DCE-CT with 18FDG-PETCT is more accurate andor 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-PETCT 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-CTIMPNon interventional trial
Concomitant Therapy As per local practice
Primary Trial Endpoints
Primary outcome measures will include diagnostic test characteristics sensitivity specificity accuracy for 18FDG-PETCT 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-PETCT with incorporation of CT appearances and combined DCE-CT18FDG-PET The incidence of incidental extra-thoracic findings on 18FDG-PETCT subsequent investigations and costs will also be determined
Total Number of Sites up to 14
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN30784948 | OTHER | None | None |
| project number 0922117 | OTHER_GRANT | NIHR-HTA | None |