MR Characterisation/Localisation of Breast Cancer

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01567137

Enrollment

Registered

2012-03-30

Start date

2007-11-30

Completion date

2011-11-30

Last updated

2016-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United Kingdom

Outcome results