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CompletedNCT01567137Updated Jun 15, 2016

MR Characterisation/Localisation of Breast Cancer

An observational study in Breast Cancer, sponsored by Institute of Cancer Research, United Kingdom. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-06-15.

Sponsored by Institute of Cancer Research, United Kingdom · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
16
Ages
18 Years to 80 Years
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer

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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 16 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

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Lead sponsor

Institute of Cancer Research, United Kingdom is the lead sponsor of 111 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

Exclusion Criteria:

  • Multifocal disease
  • Previous surgery to ipsilateral breast
  • Neoadjuvant chemotherapy
  • Ferromagnetic implants
  • Claustrophobia
  • Cup size DD or greater
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
16 participants (actual)
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4 years

Secondary outcomes

  1. 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.

    Time frame: 4 years

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Study locations

1 site
  • Royal Marsden NHS Foundation Trust
    Sutton, Surrey SM2 5PT, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01567137
Lead sponsor
Institute of Cancer Research, United Kingdom
Responsible party
NdeSouza (Professor of Translational Imaging, Institute of Cancer Research, United Kingdom) — Principal investigator
First posted
Mar 30, 2012
Start date
Nov 2007
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Jun 15, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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