Can Dynamic Contrast Enhanced Computed Tomography (DCE-CT) scans aid in the diagnosis of early stage lung cancer and are they cost effective?

ISRCTN	ISRCTN30784948
DOI	https://doi.org/10.1186/ISRCTN30784948
ClinicalTrials.gov number	NCT02013063
Secondary identifying numbers	HTA: 09/22/117

Submission date: 28/05/2012
Registration date: 30/05/2012
Last edited: 16/03/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-at-2-different-ways-to-diagnose-lung-cancer-sputnik

Contact information

Prof Steve George
Scientific

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

Study information

Study design	Prospective observational study
Primary study design	Observational
Secondary study design	Other
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Accuracy and cost-Effectiveness of Dynamic Contrast Enhanced Computed Tomography in the characterisation of solitary pulmonary nodules
Study 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(s)	Not provided at time of registration
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
Primary outcome measure	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 study start date	01/09/2012
Overall study end date	30/04/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	375
Total final enrolment	355
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 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	16/12/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Mailpoint 805

Southampton
SO16 6YD
United Kingdom

Sponsor information

University Hospital Southampton NHS Foundation Trust (UK)
Hospital/treatment centre

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

"ROR"	https://ror.org/0485axj58

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2020	03/11/2020	Yes	No
Protocol article	protocol	14/10/2016	17/12/2020	Yes	No
Results article	Health Technology Assessment programme results publication	01/03/2022	16/03/2022	Yes	No

Editorial Notes

16/03/2022: Publication reference added.
17/12/2020: Publication reference added.
03/11/2020: Publication reference and total final enrolment number added.
14/02/2020: ClinicalTrials.gov number added.
22/08/2018: The recruitment end date has been changed from 30/11/2016 to 16/12/2016
17/08/2018: The following changes have been made to the trial record:
1. The overall trial end date has been changed from 31/05/2017 to 30/04/2019
2. The recruitment end date has been changed from 31/05/2017 to 30/11/2016