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MR Characterisation/Localisation of Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01567137
First Posted: March 30, 2012
Last Update Posted: June 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
NdeSouza, Institute of Cancer Research, United Kingdom
  Purpose

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.


Condition
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)
  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567137


Locations
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
ClinicalTrials.gov Identifier: NCT01567137     History of Changes
Other Study ID Numbers: CCR 2995 07/H0806/85
First Submitted: March 28, 2012
First Posted: March 30, 2012
Last Update Posted: June 15, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases