Single Pulmonary Nodule Investigation

Malignant Neoplasm of Lung Clinical Trial

— SPUtNIk  

Official title:

Accuracy and Cost-Effectiveness of Dynamic Contrast Enhanced Computed Tomography in the Characterisation of Solitary Pulmonary Nodules

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02013063
• Other study ID #: RHM RAD0030
• Secondary ID: ISRCTN30784948pr
• Status: Recruiting
• Phase: N/A
• First received: December 11, 2013
• Last updated: October 17, 2016
• Start date: August 2012
• Est. completion date: October 2018

Study information

• Verified date: October 2016
• Source: University Hospital Southampton NHS Foundation Trust.
• Contact: Jackie Madden, PhD
• Phone: 00442381203833
• Email: jm24[@]soton.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health Research
• Study type: Observational

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 375
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Neoplasm of Lung
• Multiple Pulmonary Nodules
• Neoplasms
• Solitary Pulmonary Nodule

Locations

Country	Name	City	State
United Kingdom	NHS Grampian	Aberdeen
United Kingdom	Brighton and Sussex University Hospitals Nhs Trust	Brighton
United Kingdom	Papworth Hospital Nhs Foundation Trust	Cambridge
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	Leeds Teaching Hospitals Nhs Trust	Leeds
United Kingdom	University College London Hospitals Nhs Foundation Trust	London
United Kingdom	University Hospital of South Manchester Nhs Foundation Trust	Manchester
United Kingdom	Southampton University Hospitals Nhs Trust	Southampton	Hampshire
United Kingdom	Western Sussex Hospitals NHS Foundation Trust	Worthing	Sussex

Sponsors (12)

Lead Sponsor

Collaborator

University Hospital Southampton NHS Foundation Trust.

Brighton and Sussex University Hospitals NHS Trust, East and North Hertfordshire NHS Trust, NHS Grampian, NHS Greater Glasgow and Clyde, Oxford University Hospitals NHS Trust, Papworth Hospital NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, University College London Hospitals, University Hospital of South Manchester NHS Foundation Trust, University of Southampton, Western Sussex Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years	No
Primary	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.	2 years	No
Secondary	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.	2 years	No
Secondary	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.	2 years	No