Comparative effectiveness of magnetic resonance (MR) imaging in women with breast cancer

ISRCTN	ISRCTN57474502
DOI	https://doi.org/10.1186/ISRCTN57474502
Secondary identifying numbers	HTA 99/27/05

Submission date: 19/06/2002
Registration date: 19/06/2002
Last edited: 25/10/2022

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-magnetic-resonance-imaging-to-help-diagnose-breast-cancer

Contact information

Prof Lindsay Turnbull
Scientific

Centre for Magnetic Resonance Imaging
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Phone	+44 (0)1482 674082
Email	L.W.Turnbull@hull.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Comparative effectiveness of magnetic resonance (MR) imaging in women with breast cancer
Study acronym	COMICE
Study hypothesis	Study hypothesis added as of 10/06/2008: The overall aim of this randomised controlled trial is to determine the potential benefits to the patient and to the NHS of the addition of MR imaging to the routine techniques employed for loco-regional staging of primary breast cancer. Please note that as of 10/06/2008 this trial record was extensively amended. The following changes have taken place: 1. Anticipated end date has been updated from 30/09/2008 to 31/01/2008 2. Study hypothesis was added 3. Information on ethics approval was added 4. Participants - exclusion criteria were added 5. Secondary outcome measures were added Please note that, as of 11/05/2009, the anticipated end date has been updated from 31/01/2008 to 30/09/2008.
Ethics approval(s)	Added as of 10/06/2008: The North West Multi-centre Research Ethics Committee. Date of approval: 04/09/2001 (ref: MREC 01/8/61). In addition, each participating centre received an approval from a local ethics committee.
Condition	Breast cancer
Intervention	Patients are randomised to receive either the standard triple assessment (mammography, ultrasound, core biopsy/fine needle aspiration [FNA]) or standard triple assessment plus an MR scan. Randomised controlled trial of women with primary breast cancer (PBC) scheduled for WLE following triple assessment (TA). Participants will be recruited over 36 months and a minimisation algorithm used to balance the random allocation in respect of key prognostic variables. Women will be randomised to MRI before WLE or will proceed directly to WLE. MR images will be evaluated by radiologists with prior knowledge of XRM and US results. Following review of XRM, US & MRI three outcomes are possible: MR findings equivalent to XRM/ US - proceed to WLE; multifocal lesions present or tumour size greater on MRI - surgical management reviewed; or MC disease detected. If MC lesions are <5mm patients proceed to WLE, but if >5mm MR-localised, US-guided FNAC/ core biopsy required. Biopsy -ve patients will proceed to WLE, but if +ve surgical management will be reviewed. Repeat MRI on women with < 5mm lesions or FNAC/ core biopsy -ve >5mm lesions will be performed at 1 year. Detailed serial sectioning of excised specimens will allow correlation with results of XRM, US and MRI. Setting: Multi-centre, hospital based study involving multidisciplinary groups in Bolton, Cardiff, Hull/ Grimsby, Leeds, London (St Mary's) and Newcastle/ Gateshead. High field (1.5T) MR systems with dedicated breast coils, fast scanning capabilities and post-processing facilities are already in place. Approximately 150-500 primary breast cancers are detected at each centre p.a., of which approximately 50% are scheduled for WLE, providing a potential trial population of 3,500. The study would be coordinated through Northern & Yorkshire Clinical Trials & Research Unit at the University of Leeds and Wales Cancer Trials Network in Cardiff. Target Population: Women with FNAC or core biopsy proven PBC scheduled for WLE after conventional triple assessment, but excluding those with contraindications to MRI or contrast medium administration. Health technologies being assessed: MRI: Multiple thin-slice (in-plane resolution 1.3 x 1.3 mm; thk 4 mm) 3D, contrast-enhanced (0.1 mmol Gd-DTPA/ kg body weight) fast spoiled gradient-echo MR sequences (temporal resolution 45 seconds), analysed using robust, easily implemented techniques (signal intensity time course evaluation) will be combined with high resolution (0.7 x 0.9 mm in plane) post-contrast fat- suppressed MR imaging for morphological information. This will be compared with XRM (medio-lateral oblique, cranio- caudal ñ paddle/ axillary views) and whole breast US (7.5 - 13 MHz linear array transducer). Sample size: Assuming MRI will reduce overall re-operation/ mastectomy rates after WLE from 15 to 10%, 1,840 women are required to detect a benefit with 90% power and 2-sided significance level of 5%. Project timetables/ recruitment rate: 0-3 months: study-specific data-base; preparation of MREC application; piloting of data collection forms; 3-39 months: patient recruitment & data collection; 49-51 months: analysis of intermediate and 66-69 months analysis of final trial data & preparation of manuscript(s). Assuming 50% of women with PBC are scheduled for WLE, a recruitment rate of 52.5% is required, and is considered achievable with study-specific Research Nurses.
Intervention type	Other
Primary outcome measure	Cost and outcome measures: 1. Comparison of re-operation/ mastectomy/RTX rates after TA or TA and MRI. 2. IBTR rate at 5 yrs for patients imaged ñ MRI. 3. Extrapolated life expectancy and quality adjusted life expectancy. 4. Quantification of patient satisfaction with management decisions and quality of life measurements using FACT-B, HADS score, EQ-5D and ad-hoc questionnaire to examine concerns about tumour recurrence. 5. Differential resource implications in first year of TA vs TA + MRI, including measurement of indirect and personal costs incurred by patients. 6. Estimation of later costs due to differential rates of recurrence related to life expectancy and quality adjusted life expectancy. 7. Determination of sub-groups most likely to benefit from addition of DCE-MRI. 8. Effectiveness of XRM, US and DCE-MRI imaging.
Secondary outcome measures	Added as of 10/06/2008: 1. Recurrence rate 2. Chemotherapy/radiotherapy interventions 3. Quality of life and patient satisfaction 4. Risk factors for referral for MR imaging 5. Effectiveness of imaging 6. Change in clinical management 7. Clinical significance of <5 mm MR-only detected lesions
Overall study start date	01/06/2001
Overall study end date	30/09/2008

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target number of participants	1,840
Total final enrolment	1623
Participant inclusion criteria	Patients scheduled for wide local excision for primary breast cancer
Participant exclusion criteria	Added as of 10/06/2008: 1. Medically unstable 2. Known contraindication to magnetic resonance (MR) scanning 3. Known to have had an allergic reaction associated with previous administration of paramagnetic contrast agent or have a severe allergic diathesis 4. Require renal dialysis 5. Have undergone chemotherapy/ hormonal therapy for cancer of the contralateral breast (or other sites) in the previous 12 months or have chemotherapy planned to any site before their breast surgery 6. Have had surgery or radiotherapy for cancer to the ipsilateral breast 7. Have had surgery to the ipsilateral breast within the previous 4 months for benign breast disease 8. Have a history of serious breast trauma within the last 3 months 9. Pregnant or breast feeding 10. Disability preventing MR scanning in the prone position 11. Under the care of a breast surgeon recruiting into the ALMANAC Trial
Recruitment start date	01/06/2001
Recruitment end date	30/09/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Centre for Magnetic Resonance Imaging

Hull
HU3 2JZ
United Kingdom

Sponsor information

Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre

Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
England
United Kingdom

Website	http://www.hey.nhs.uk
"ROR"	https://ror.org/01b11x021

Funders

Funder type

Government

Health Technology Assessment Programme
Government organisation / National government

Alternative name(s): NIHR Health Technology Assessment Programme, HTA
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?
Results article	results on cost effectiveness	01/01/2010		Yes	No
Results article	results on clinical effectiveness	13/02/2010		Yes	No
Plain English results			25/10/2022	No	Yes

Editorial Notes

25/10/2022: Cancer Research UK plain English results link and total final enrolment added.