MR Characterisation/Localisation of Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Sensitivity of MR techniques in detecting histopathologically-identified multifocal and multicentric lesions

Time frame: 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 outcomes

Closeness of agreement between MR techniques and histopathology in localising satellite lesions relative to the index tumour.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Registry information

Official study title

Using Magnetic Resonance Techniques to Improve the Characterisation and Localisation of Breast Cancer

Important dates

Study start: 2007
Primary completion: 2011
Study completion: 2011
First posted: Mar 30, 2012
Registry last updated: Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed