Condition category
Cancer
Date applied
28/05/2012
Date assigned
30/05/2012
Last edited
08/04/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Prof Steve George

ORCID ID

Contact details

Mailpoint 805
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA: 09/22/117

Study information

Scientific title

Accuracy and cost-Effectiveness of Dynamic Contrast Enhanced Computed Tomography in the characterisation of solitary pulmonary nodules

Acronym

SPutNIk

Study hypothesis

A DCE-CT scan, either alone or in conjunction with fluorodeoxyglucose positron emission tomography (FDG-PET)/CT scan, can aid in the early diagnosis of lung cancer in patients where a single pulmonary nodule has been detected by conventional CT scan and that this is more cost effective than monitoring with conventional CT scans for up to two years.

More details can be found at http://www.hta.ac.uk/project/2790.asp

Ethics approval

Not provided at time of registration

Study design

Prospective observational study

Primary study design

Observational

Secondary study design

Other

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diagnosis of early stage lung cancer in a population that have a single pulmonary nodule detected by conventional CT scan

Intervention

This is a diagnostic study involving the addition of a single DCE-CT scan, performed on the same day or within 2 weeks of a FDG-PET/CT scan which is standard NHS care for patients presenting with an SPN on conventional CT scan.

Patients will be followed up for a period of two years or until diagnosis under standard NHS care.

Outcomes of early stage lung cancer or not will be compared to scan data from DCE-CT scans ± FDG-PET/CT scans to assess accuracy of diagnosis and cost effectiveness of DCE-CT scans.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Diagnostic test characteristics of sensitivity, specificity and accuracy for both FDG-PET/CT and DCE-CT scans in relation to a subsequent clinical diagnosis of lung cancer.
2. Economic model will include accuracy, estimated life expectancy, and quality adjusted life years (QALYs)
3. 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

1. Diagnostic test characteristics for FDG-PET/CT with incorporation of CT appearances and combined DCE-CT/FDG-PET scans.
2. Incidence of incidental extra-thoracic findings on FDG-PET/CT and subsequent investigations and costs will also be determined.

Overall trial start date

01/09/2012

Overall trial end date

31/05/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. A soft tissue solitary dominant pulmonary nodule of ≥ 8mm and ≤ 30mm on axial plane, measured on lung window using conventional CT scan with no other ancillary evidence strongly indicative of malignancy (e.g. distant metastases) or unequivocal local invasion.
2. 18 years of age or over at time of providing consent
3. Able and willing to consent to study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

375

Participant exclusion criteria

1. Pregnancy
2. History of malignancy within the past 2 years
3. Confirmed aetiology of the nodule
4. Biopsy of nodule prior to DCE-CT scan
5. Contra-indication to potential radiotherapy or surgery
6. Contra indication to scans (assessed by local procedures)

Recruitment start date

01/09/2012

Recruitment end date

31/05/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mailpoint 805
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

University Hospital Southampton NHS Foundation Trust (UK)

Sponsor details

Research and Development
SGH - Level E
Laboratory and Pathology Block
SCBR - MP 138
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment (HTA) (UK) (ref: 09/22/117)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes