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

Not Applicable

Completed

• Conditions: Breast cancer; Cancer; Breast

• Registration Number: ISRCTN57474502
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust (UK)

Brief Summary

2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20025837 results on cost effectiveness 2010 Results article in http://www.ncbi.nlm.nih.gov/pubmed/20159292 results on clinical effectiveness

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-06-19
• Study Completion: 2008-09-30
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1623

Inclusion Criteria

Patients scheduled for wide local excision for primary breast cancer

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Cost and outcome measures:<br> 1. Comparison of re-operation/ mastectomy/RTX rates after TA or TA and MRI.<br> 2. IBTR rate at 5 yrs for patients imaged ñ MRI.<br> 3. Extrapolated life expectancy and quality adjusted life expectancy.<br> 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.<br> 5. Differential resource implications in first year of TA vs TA + MRI, including measurement of indirect and personal costs incurred by patients.<br> 6. Estimation of later costs due to differential rates of recurrence related to life expectancy and quality adjusted life expectancy.<br> 7. Determination of sub-groups most likely to benefit from addition of DCE-MRI. 8. Effectiveness of XRM, US and DCE-MRI imaging.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Added as of 10/06/2008:<br> 1. Recurrence rate<br> 2. Chemotherapy/radiotherapy interventions<br> 3. Quality of life and patient satisfaction<br> 4. Risk factors for referral for MR imaging<br> 5. Effectiveness of imaging<br> 6. Change in clinical management<br> 7. Clinical significance of <5 mm MR-only detected lesions<br>