MR Characterisation/Localisation of Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567137
• Other study ID #: CCR 2995 07/H0806/85
• Status: Completed
• Phase: N/A
• First received: March 28, 2012
• Last updated: June 14, 2016
• Start date: November 2007
• Est. completion date: November 2011

Study information

• Verified date: June 2016
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of MR techniques in detecting histopathologically-identified multifocal and multicentric lesions	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.	4 years	No
Secondary	Closeness of agreement between MR techniques and histopathology in localising satellite lesions relative to the index tumour.	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.	4 years	No