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| [ Print-friendly version ] |
| Comparative effectiveness of magnetic resonance (MR) imaging in women with breast cancer |
| ISRCTN | ISRCTN57474502 |
| ClinicalTrials.gov identifier | |
| Public title | Comparative effectiveness of magnetic resonance (MR) imaging in women with breast cancer |
| Scientific title | |
| Acronym | COMICE |
| Serial number at source | HTA 99/27/05 |
| Study hypothesis |
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 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. |
| Ethics approval |
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. |
| Study design | Randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Breast cancer |
| Participants - inclusion criteria | Patients scheduled for wide local excision for primary breast cancer |
| Participants - 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 |
| Anticipated start date | 01/06/2001 |
| Anticipated end date | 31/01/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1,840 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Lindsay Turnbull |
| Address |
Centre for Magnetic Resonance Imaging
Hull Royal Infirmary Anlaby Road |
| City/town | Hull |
| Zip/Postcode | HU3 2JZ |
| Country | United Kingdom |
| Tel | +44 (0)1482 674082 |
| Fax | +44 (0)1482 320137 |
| L.W.Turnbull@hull.ac.uk | |
| Sponsor | Hull and East Yorkshire Hospitals NHS Trust (UK) |
| Address |
Hull Royal Infirmary
Anlaby Road |
| City/town | Hull |
| Zip/Postcode | HU3 2JZ |
| Country | United Kingdom |
| Sponsor website: | http://www.hey.nhs.uk |
| Date applied | 19/06/2002 |
| Last edited | 10/06/2008 |
| Date ISRCTN assigned | 19/06/2002 |
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