The role of advanced brain magnetic resonance imaging techniques in small cell lung cancer

ISRCTN	ISRCTN44860775
DOI	https://doi.org/10.1186/ISRCTN44860775
Secondary identifying numbers	CLUB01 version 1.0 May 2009

Submission date: 22/06/2009
Registration date: 28/09/2009
Last edited: 27/07/2022

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-using-advanced-type-MRI-scan-look-risk-factors-small-cell-lung-cancer-spread-club-01

Contact information

Dr Susan Harden
Scientific

Oncology Centre, Box 193
Cambridge University Hospitals NHS Foundation Trust
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Email	susan.harden@addenbrookes.nhs.uk

Study information

Study design	Non-randomised controlled single-centre study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please contact CCTC at Addenbrooke's Hospital: +44 (0)1223 216083 to request a patient information sheet
Scientific title	A non-randomised controlled single centre study to investigate the role of advanced brain magnetic resonance imaging techniques in small cell lung cancer
Study acronym	CLUB01
Study objectives	We hypothesise that by developing ways to look for subtle changes in magnetic resonance imaging (MRI) images before the cancer deposits (metastases) themselves are big enough to be visualised by current methods, we may be able to predict which patients are most at risk for developing brain metastases.
Ethics approval(s)	Cambridgeshire 1 Research Ethics Committee (REC), ref: 09/H0304/59, expected to be approved on 21/07/2009
Health condition(s) or problem(s) studied	Small cell lung cancer
Intervention	This is a single centre non-randomised observational imaging feasibility study. There will be a maximum of 4 MRI scans (interventions) over a 1 year period and the total duration recruitment will be 2 years, therefore a study duration of 3 years to complete the interventions with routine clinical follow-up to 5 years as standard.
Intervention type	Other
Primary outcome measure	Identification of the subset of SCLC patients at high risk for developing brain metastases, based on novel imaging at diagnosis, correlated retrospectively with clinical outcome.
Secondary outcome measures	Radiological disease progression: 1. Local incidence of asymptomatic brain metastases detected by conventional MRI at diagnosis 2. Local incidence of brain metastases detected after chemotherapy by conventional MRI
Overall study start date	01/09/2009
Completion date	09/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	20 sequential patients
Total final enrolment	16
Key inclusion criteria	1. Ability to give written informed consent 2. Aged greater than 18 years, either sex 3. Histologically or cytologically confirmed small cell lung cancer 4. No previous malignancy 5. No prior chemotherapy 6. Satisfactory renal function (ethylenediaminetetraacetic acid [EDTA] clearance greater than 60 ml/min) 7. Satisfactory World Health Organization (WHO) performance status 0, 1 or 2
Key exclusion criteria	1. Prior chemotherapy or radiotherapy to primary tumour 2. Central nervous system (CNS) disease 3. Previous or coexistent malignancies 4. Pregnancy or breastfeeding 5. Any other medical condition making participation in a clinical trial undesirable
Date of first enrolment	01/09/2009
Date of final enrolment	09/11/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Cambridge University Hospitals NHS Foundation Trust

Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Trust R&D Dept, Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
England
United Kingdom

Website	http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html
"ROR"	https://ror.org/04v54gj93

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

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?
Plain English results			27/07/2022	No	Yes

Editorial Notes

27/07/2022: Cancer Research UK plain English results summary link and total final enrolment added.
04/07/2017: No publications found in PubMed, verifying study status with principal investigator.