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Southampton Clinical Trials Unit

SPUTNIK Trial

Trial Overview

Trial Team

Essential Trial Documentation

Useful Downloads

Title

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

Description

A prospective, observational study to assess the accuracy and cost effectiveness of dynamic contrast enhanced computed tomography in the characterisation of Solitary Pulmonary Nodules. 

Objectives

Primary Objetives: 

  • 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 and DCE-CT undertaken for the characterisation of SPNs and model their impact on cost-effectiveness.

Trial Design

Non interventional, prospective observational study 

Trial Status

In follow-up 

Population

Patients with a solitary dominant pulmonary nodule between 8mm and 30mm without confirmed aetiology 

Trial Team:

Senior Trial Manager:

Lou Little (023 8120 5331)

Trial Manager:

Lorraine Durcan (023 8120 5160)

Clinical Data Coordinator:

Peter Navin (023 8120 5321)

Contact information

Email: sputnik@soton.ac.uk

Fax: 0844 7740 621

Essential Trial Documents

SPUtNIk - Protocol v7 07-Oct-2016

Trial Logs

SPUtNIk - Master Patient List

SPUtNIk - Patient Screening and Recruitment Log v3 26-Jul-2013

SPutNIk - Scan Log v1 05-Oct-2012

CRFs and Datasheets Documents

SPutNIk - IPCARD SPN Questionairre v2 15-Sep-2015

SPutNIk - Informed Consent Form v8 15-Sep-2015

SPutNIk - MRIS - Patient Flagging Form v1 13-Nov-2012

SPutNIk - Site Registration Form v1 25-Nov-2013

SPutNIk - Patient Information Sheet v8 15-Sep-2015

SPutNIk - Patient Card v1 12-Sep-2012

SPutNIk - Consultant Letter v1 20-Mar-2013

SPutNIk - DCE Radiographer Data Sheet v1

SPutNIk - PET Radiology Sheet v2

SPutNIk - Initial Information Sheet v1

SPutNIk - Introductory Letter v1 05-Feb-2014

SPutNIk - Instructions for SAE Reporting v1 31-Oct-2014

SPutNik - SAE Report Form v1 31-10-14

SPutNik - ECRF 1 v2 21-Jun-2016

SPutNik - ECRF 2 v2 21-Jun-2016

SPutNik - ECRF 3 v1 21-Jan-2015

SPutNik - eCRF data entry guidelines v6 27-May-2016

SPUtNIk - Training InForm eCRF v1

Trial Letters

SPutNIk - Consultant Letter v1 20-Mar-2013

SPutNIk - GP Letter v2 19-Jul-2012

SPutNIk - Introductory Letter v1 05-Feb-2014

SPUtNIk - Second IPCARD Letter-1 v1 18-Jun-2015

SPUtNIk - Second IPCARD Letter-2 v1 18-Jun-2015

Trial Reports

SPutNIK - Initial CT report 27-Nov-2013

SPUtNik - DCE-CT report v2 13-Oct-2014

SPUtNik - 18FDG -PET-CT report  v2 13-Oct-2014

Newsletters

SPUtNIk Newsletter 1- Dec 2012

SPUtNIk Newsletter 2 - Feb 2013

SPUtNIk Newsletter 3 - May 2013

SPUtNIk Newsletter 4 - July 2013

SPUtNIk Newsletter 5 - Dec 2013

SPUtNIk Newsletter 6 - Feb 2014

SPUtNIk Newsletter 7- Apr 2014

SPUtNik Newsletter 8 - Jun 2014

SPUtNik Newsletter 9 - Aug 2014

SPUtNIk Newsletter 10 - May 2015

SPUtNIk Newsletter 11 - July 2015

SPUtNIk Newsletter 12 - Oct 2015

SPUtNIk Newsletter 13 - Dec 2015

SPUtNIk Newsletter 14 - March 2016

SPUtNIk Newsletter 15 - July 2016

SPUtNIk Newsletter 17 - January 2017

Update

SPUtNIk Summary of Changes Am13

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