The University of Southampton
Clinical Trials Unit

SPUTNIK Trial

Senior Trial Manager: Lou Little

Trial Manager: Roy Raphael

Data Officer: Kathrin Eichhorst

 

Trial documents

SPUtNIk Protocol v7.0 07-10-16

 

Trial logs

2.1 SPUtNIk Master Patient List.docx

2.3 SPUtNIk Patient Screening and Recruitment Log v3 26-07-13.docx

2.6 SPutNIk Scan Log v1 05-10-12.docx

 

CRFs and datasheets documents

SPutNIk IPCARD SPN Questionairre v2.0 15-09-15

SPutNIk Informed Consent Form v8.0 15-09-15 in track

SPutNIk MRIS - Patient Flagging Form v1 13-11-12.docx

SPutNIk Site Registration Form v1 25-11-13.docx

SPutNIk Patient Information Sheet v8.0 15-09-15

SPutNIk Patient Card v1 12-09-12.docx

SPutNIk Consultant Letter v1 20-03-13.docx

SPutNIk DCE Radiographer Data Sheet v1. docx

SPutNIk PET Radiology Sheet v2.docx

SPutNIk Initial Information Sheet v1. docx

SPutNIk Introductory Letter v1. 05-02-2014.doc

SPutNIk Instructions for SAE Reporting v1.0 31-10-14.doc

SPutNik SAE Report Form -v1 31-10-14.doc

SPutNik ECRF 1 v2 dated 21-06-2016

SPutNik ECRF 2 v2 dated 21-06-2016

SPutNik ECRF 3 v1 dated 21-01-2015

SPutNik eCRF data entry guidelines v6.0 270516

SPUtNIk Training InForm eCRF v1.0

 

 

Trial letters

SPutNIk Consultant Letter v1 20-03-13.docx

SPutNIk GP Letter v2 19-07-12.docx

SPutNIk Introductory Letter v1. 05-02-2014.doc

SPUtNIk Second IPCARD Letter-1 v1.0 18-06-15

SPUtNIk Second IPCARD Letter-2 v1.0 18-06-15

 

Trial reports

SPutNIK Initial CT report 27-11-13.doc

SPUtNik DCE-CT report v2.0 13-102014.doc

SPUtNik 18FDG -PET-CT report  v2.0 13-10-2014.doc

 

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

Status

in follow-up

Useful Downloads

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

Population

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

Consideration

Non interventional, prospective observational study

Duration

Patients have a 18FDG-PET scan and a DEC-CT scan followed by standard local follow up for 2 years

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