Single Pulmonary Nodule Investigation

NCT02013063 | Unknown DMC

• 3 other identifiers: RHM RAD0030ISRCTN30784948project number 09/22/117
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 9

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)-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

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• Effectiveness of DCE-CT scans combined with FDG-PET scans to diagnose early lung cancer in SPN

  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

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospital Chest Clinics PET referal centres

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (9)

Southampton University Hospitals Nhs Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

Western Sussex Hospitals NHS Foundation Trust

Worthing, Sussex, BN112DH, United Kingdom

RECRUITING

NHS Grampian

Aberdeen, AB25 2ZN, United Kingdom

RECRUITING

Brighton and Sussex University Hospitals Nhs Trust

Brighton, BN2 5BE, United Kingdom

RECRUITING

Papworth Hospital Nhs Foundation Trust

Cambridge, CB23 3RE, United Kingdom

RECRUITING

NHS Greater Glasgow and Clyde

Glasgow, G116NT, United Kingdom

RECRUITING

Leeds Teaching Hospitals Nhs Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

University College London Hospitals Nhs Foundation Trust

London, NW1 2PG, United Kingdom

RECRUITING

University Hospital of South Manchester Nhs Foundation Trust

Manchester, M23 9LT, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 36087795 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.

  PMID: 35289267 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.

  PMID: 34887348 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.

  PMID: 33130961 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steve George, MD,FRCP

  University of Southampton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jackie Madden, PhD

CONTACT

00442381203833; jm24@soton.ac.uk

Louisa Little

CONTACT

00442381205331; lal@soton.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: December 17, 2013
• Study Start: August 1, 2012
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (9)