The QuaRTUS Study

  • Research type

    Research Study

  • Full title

    Quantification of breast radiotherapy associated late toxicity using novel ultrasound techniques (The QuaRTUS Study)

  • IRAS ID

    160918

  • Contact name

    Emma J Harris

  • Contact email

    emma.harris@icr.ac.uk

  • Sponsor organisation

    Institute of Cancer Research

  • Clinicaltrials.gov Identifier

    NCT02388230

  • Duration of Study in the UK

    1 years, 5 months, 29 days

  • Research summary

    Around 20% of women who receive breast radiotherapy (RT) experience moderate to severe breast hardening and shrinkage. These side-effects have been shown to be important factors influencing quality of life after breast radiotherapy. It is thought that the likelihood of developing these side-effects is related to the presence of underlying genetic differences in patients. In order to identify these genetic differences, we need accurately quantify the severity of these side-effects. So far, we have used clinical assessment conducted by a clinician but this is not specific enough for us to be able to relate development of breast shrinkage and hardening to genetic differences. For example, clinical assessment often fails to distinguish between hardness due to swelling (known as oedema) and hardness due to generalised radiation-induced scarring (known as fibrosis). Ultrasound techniques, however, may be able to help us quantify and characterise radiotherapy-associated changes in breast tissue allowing for better correlation with genetic abnormalities. Once genetic changes can be identified, we will in future be able to adjust breast RT treatments (or add drugs) to help reduce side-effects in women at higher genetic risk of side-effects.
    This study tests the ability of two forms of ultrasound, shear-wave elastography (USE) and ultrasound backscatter spectroscopy (UBS), to quantify and characterise breast shrinkage and firmness with a view to using these techniques to measure the late side-effects of breast RT to study the underlying causes of radiotherapy toxicity.

  • REC name

    London - Surrey Research Ethics Committee

  • REC reference

    15/LO/1178

  • Date of REC Opinion

    9 Jul 2015

  • REC opinion

    Favourable Opinion