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MR Characterisation/Localisation of Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
NdeSouza, Institute of Cancer Research, United Kingdom Identifier:
First received: March 28, 2012
Last updated: June 14, 2016
Last verified: June 2016

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.

Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Using Magnetic Resonance Techniques to Improve the Characterisation and Localisation of Breast Cancer

Resource links provided by NLM:

Further study details as provided by NdeSouza, Institute of Cancer Research, United Kingdom:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

Enrollment: 16
Study Start Date: November 2007
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women with confirmed breast cancer

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01567137

United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
  More Information

Responsible Party: NdeSouza, Professor of Translational Imaging, Institute of Cancer Research, United Kingdom Identifier: NCT01567137     History of Changes
Other Study ID Numbers: CCR 2995 07/H0806/85
Study First Received: March 28, 2012
Last Updated: June 14, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on August 18, 2017