The Royal Marsden
Sutton, SM2 5PT, United Kingdom
NCT Number: NCT02388230
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, the severity of side-effects needs to be accurately measured. Currently, clinical assessments are conducted by a clinician but this is not specific enough 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 quantify and characterise radiotherapy-associated changes in breast tissue allowing for better correlation with genetic abnormalities. Once genetic changes can be identified, adjustment of breast RT treatments (or add drugs) to help reduce side-effects in women at higher genetic risk of side-effects may be possible.
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.
Principle research question: Can a new ultrasound technique (shear wave elastography) measure radiation-induced side-effects in women who have received breast radiotherapy?
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Notify Me18 year and older
Female
Observational
Sutton, SM2 5PT, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Two patient groups will be included:
Exclusion criteria
Time frame: Outcome measures will be assessed for each patient during their imaging appointment only. For group 1 patients imaging takes place more than 4 years post radiotherapy, for group 2 patients imaging takes place 3 months to 2 years post radiotherapy.
Difference in Young's Modulus measured in the irradiated breast and Young's Modulus measured in the non-irradiated breast in patients with reported breast hardness.
Institute of Cancer Research, United Kingdom
Other
Quantification of Breast RadioTherapy Associated Late Toxicity Using Novel
Acronym: QuaRTUS
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