Streamlining Staging of Lung cancer with Whole Body MRI

ISRCTN	ISRCTN50436483
DOI	https://doi.org/10.1186/ISRCTN50436483
Protocol serial number	Streamline L
Sponsor	University College London (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK) ref: 10/68/01

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 of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-mri-scan-diagnose-non-small-cell-lung-cancer-streamline-l

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

Primary study design	Observational
Study design	Multicentre comparison
Secondary study design	Multi-centre
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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.
Completion date	01/01/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	250
Total final enrolment	353
Key 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.
Key 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
Date of first enrolment	01/10/2012
Date of final enrolment	01/04/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University College London Hospitals

London
NW1 2BU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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