Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Single Pulmonary Nodule Investigation (SPUtNIk)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by University Hospital Southampton NHS Foundation Trust.
Sponsor:
Collaborators:
University of Southampton
Brighton and Sussex University Hospitals NHS Trust
University College London Hospitals
Oxford University Hospitals NHS Trust
Papworth Hospital NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
University Hospital of South Manchester NHS Foundation Trust
East and North Hertfordshire NHS Trust
NHS Grampian
NHS Greater Glasgow and Clyde
Western Sussex Hospitals NHS Trust
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier:
NCT02013063
First received: December 11, 2013
Last updated: November 21, 2014
Last verified: November 2014
  Purpose

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


Condition
Malignant Neoplasm of Lung

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Accuracy and Cost-Effectiveness of Dynamic Contrast Enhanced Computed Tomography in the Characterisation of Solitary Pulmonary Nodules

Resource links provided by NLM:


Further study details as provided by University Hospital Southampton NHS Foundation Trust.:

Primary Outcome Measures:
  • Effectiveness of DCE-CT scans and FDG-PET scans to diagnose early lung cancer in SPN [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • cost effectiveness of using DCE-CT scans in the diagnosis of early lung cancer in SPN [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Effectiveness of DCE-CT scans combined with FDG-PET scans to diagnose early lung cancer in SPN [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Diagnostic test characteristics combined DCE-CT/18FDG-PET in relation to a subsequent clinical diagnosis of lung cancer.

  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Diagnostic test characteristics for 18FDG-PET/CT with incorporation of CT appearances in relation to a subsequent clinical diagnosis of lung cancer.


Estimated Enrollment: 375
Study Start Date: August 2012
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Hospital Chest Clinics PET referal centres

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013063

Contacts
Contact: Jackie Madden, PhD 00442381203833 jm24@soton.ac.uk
Contact: Louisa Little 00442381205331 lal@soton.ac.uk

Locations
United Kingdom
Southampton University Hospitals Nhs Trust Recruiting
Southampton, Hampshire, United Kingdom, SO16 6YD
Principal Investigator: Anindo Dr Banerjee, PhD         
Western Sussex Hospitals NHS Foundation Trust Recruiting
Worthing, Sussex, United Kingdom, BN112DH
Contact: Nick Adams, MD FRCP         
NHS Grampian Recruiting
Aberdeen, United Kingdom, AB25 2ZN
Principal Investigator: Lesley Gomersall, MD         
Brighton and Sussex University Hospitals Nhs Trust Recruiting
Brighton, United Kingdom, BN2 5BE
Principal Investigator: Sabina Dr Dizdarevic, MD         
Papworth Hospital Nhs Foundation Trust Recruiting
Cambridge, United Kingdom, CB23 3RE
Principal Investigator: Nagmi Dr Qureshi, M.B.         
NHS Greater Glasgow and Clyde Recruiting
Glasgow, United Kingdom, G116NT
Principal Investigator: Sai Han, MBChB         
Leeds Teaching Hospitals Nhs Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Principal Investigator: Mathhew Dr Callister, BM PhD         
University College London Hospitals Nhs Foundation Trust Recruiting
London, United Kingdom, NW1 2PG
Principal Investigator: Ashley Dr Groves, MBBS         
University Hospital of South Manchester Nhs Foundation Trust Recruiting
Manchester, United Kingdom, M23 9LT
Principal Investigator: Philip Dr Crosbie, PhD         
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust.
University of Southampton
Brighton and Sussex University Hospitals NHS Trust
University College London Hospitals
Oxford University Hospitals NHS Trust
Papworth Hospital NHS Foundation Trust
The Leeds Teaching Hospitals NHS Trust
University Hospital of South Manchester NHS Foundation Trust
East and North Hertfordshire NHS Trust
NHS Grampian
NHS Greater Glasgow and Clyde
Western Sussex Hospitals NHS Trust
Investigators
Principal Investigator: Steve George, MD,FRCP University of Southampton
  More Information

No publications provided

Responsible Party: University Hospital Southampton NHS Foundation Trust.
ClinicalTrials.gov Identifier: NCT02013063     History of Changes
Other Study ID Numbers: RHM RAD0030, ISRCTN30784948, project number 09/22/117
Study First Received: December 11, 2013
Last Updated: November 21, 2014
Health Authority: United Kingdom: National Institute for Health Research

Keywords provided by University Hospital Southampton NHS Foundation Trust.:
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

Additional relevant MeSH terms:
Lung Neoplasms
Multiple Pulmonary Nodules
Neoplasms
Solitary Pulmonary Nodule
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014