MR Characterisation/Localisation of Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NdeSouza, Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT01567137
First received: March 28, 2012
Last updated: March 30, 2012
Last verified: March 2012
  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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 28, 2012
Last Updated: March 30, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 30, 2014