Malignant Neoplasm of Lung Clinical Trial
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.
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
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
;
Observational Model: Case-Only, Time Perspective: Prospective
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