Streamlining Staging of Lung cancer with Whole Body MRI

ISRCTN	ISRCTN50436483
DOI	https://doi.org/10.1186/ISRCTN50436483
Secondary identifying numbers	Streamline L

Submission date: 26/07/2012
Registration date: 31/07/2012
Last edited: 20/12/2019

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-mri-scan-diagnose-non-small-cell-lung-cancer-streamline-l

Study website

Contact information

Prof Stuart Taylor
Scientific

University College London Hospitals
Specialist X Ray Department
235 Euston Road
London
NW1 2BU
United Kingdom

Email	stuart.taylor1@nhs.net

Study information

Study design	Multicentre comparison
Primary study design	Observational
Secondary study design	Multi-centre
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please contact ctc.streamlineL@ucl.ac.uk to request a patient information sheet
Scientific title	Comprehensive staging of newly diagnosed lung cancer: prospective multi-centre comparison of whole body Magnetic Resonance Imaging with standard diagnostic imaging pathways
Study acronym	Streamline L
Study hypothesis	To evaluate whether early whole body magnetic resonance imaging (WB-MRI) increases per patient sensitivity for metastasis in lung cancer compared to standard NICE-approved diagnostic pathways. More details can be found at http://www.hta.ac.uk/project/2804.asp
Ethics approval(s)	Camden and Islington Research Ethics Committee, 20/08/2012, ref: 12/LO/1177
Condition	Non small cell lung cancer
Intervention	There are no treatment arms, every patient will receive a whole body MRI as part of the trial which takes about an hour. Aside from attending for the WB-MRI scan, patients shouldnt have to attend for any extra visits. All patients will be asked to complete quality of life forms (EQ-5D) at 0, 3, 6 and 9 months post staging. As part of the health economics portion of the trial, all patients will also be asked to complete patient diaries which will collect information about visits to the GP and hospital and about other medical tests and treatment for a year post staging. As part of the health psychology portion of the trial, 25 patients will take part in an interview (30 minutes) and 75 patients will be given questionnaires complete about their experience of staging at 0, 1, 3, 6, 9, and 12 months post staging. Follow-up CRFs will be completed for a year post-staging but there are no trial specific visits, this data is collected for the health economic portion of trial.
Intervention type	Other
Primary outcome measure	Per patient sensitivity for metastasis detection by whole body MRI (WB-MRI) compared to standard staging pathways in newly diagnosed non small cell lung cancer
Secondary outcome measures	1. The time and test number taken to reach, and the nature of, the first major treatment decision based on WB-MRI in comparison to standard staging pathways. 2. Diagnostic accuracy of WB-MRI and conventional staging pathways for local tumour staging and detection of metastasis in comparison to an expert derived consensus reference standard. 3. Lifetime incremental cost and cost-effectiveness of staging using WB-MRI compared to standard diagnostic pathways. 4. Patient experience of staging using WB-MRI in comparison to standard diagnostic pathways and priorities placed by patients on differing attributes related to competing staging pathways. 5. Inter-observer variability in WB-MRI analysis and affect of diagnostic confidence on staging accuracy. 6. Diagnostic accuracy of limited T1 and diffusion weighted sequences compared to full multi-sequence WB-MRI protocols.
Overall study start date	01/10/2012
Overall study end date	01/01/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	250
Total final enrolment	353
Participant inclusion criteria	1. Adult patients (18 or over) with histologically proven or clinically diagnosed primary non small cell lung cancer with potentially radically treatable disease 2. Clinically diagnosed non small cell lung cancer defined as radiological diagnosis of lung cancer on chest CT with sufficient confidence to trigger staging investigations 3. Potentially radically treatable disease defined as stage IIIb or less on diagnostic CT (ie T14, N02, M0) 4. Performance status 02 (fit to undergo surgery if indicated) 5. Patient must have given written informed consent and be willing to comply with the protocol intervention and follow up.
Participant exclusion criteria	1. Any psychiatric or other disorder likely to impact on informed consent 2. Evidence of severe or uncontrolled systemic disease which make it undesirable the for the patient to participate in the trial 3. Pregnancy 4. Contraindications to MRI (e.g. cardiac pacemaker, severe claustrophobia, inability to lie flat) 5. Unequivocal metastatic or N3 disease on diagnostic CT chest and abdomen (including M1a disease; malignant pleural effusion) 6. Further staging work up not indicated in the opinion of the MDT due to poor performance status or patient choice. 7. Histologies other than non small cell lung cancer
Recruitment start date	01/10/2012
Recruitment end date	01/04/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College London Hospitals

London
NW1 2BU
United Kingdom

Sponsor information

University College London (UK)
University/education

Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
England
United Kingdom

Website	http://www.ctc.ucl.ac.uk/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK) ref: 10/68/01

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2019	14/05/2019	Yes	No
Results article	results against ISRCTN43958015	01/12/2019	20/12/2019	Yes	No

Editorial Notes

20/12/2019: Publication reference added.
14/05/2019: Publication reference and total final enrolment added.
16/08/08: The overall trial end date was updated from 01/04/2017 to 01/01/2019