MR Characterisation/Localisation of Breast Cancer

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01567137
• Lead Sponsor: Institute of Cancer Research, United Kingdom

Brief Summary

Objective: To determine the accuracy of multi-functional magnetic resonance (MR) in detecting, localising and characterising satellite lesions in relation to an index breast tumour in order to improve definition of clinical target volume after local excision.

Hypothesis: Pre-operative multi-functional MR has high sensitivity and specificity for localising unsuspected multifocal and multicentric lesions in women diagnosed with early breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2012-03-28
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-03-30
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

• Biopsy proven invasive ductal carcinoma of the breast
• Unifocal disease
• Patient proceeding to mastectomy

Exclusion Criteria

• Multifocal disease
• Previous surgery to ipsilateral breast
• Neoadjuvant chemotherapy
• Ferromagnetic implants
• Claustrophobia
• Cup size DD or greater

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of MR techniques in detecting histopathologically-identified multifocal and multicentric lesions	4 years	Sensitivity of the MR technique in detecting histopathologically-identified multifocal/centric pre-invasive/invasive disease will be calculated (with 95% confidence intervals)from positive or negative correlates.

Secondary Outcome Measures

Name	Time	Method
Closeness of agreement between MR techniques and histopathology in localising satellite lesions relative to the index tumour.	4 years	Distance \& distribution of lesions from reference tumour will be plotted and correlated with distances and signal characteristics seen on multifunctional MR.; Pre-op MRI volume will be plotted against histopathological dimensions and examined for agreement between the two methods.; Paired Wilcoxon signed-rank tests will be used to test for systematic differences between MRI and pathology measurements.

Trial Locations

Locations (1)

Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom