MedTrace Logo

Quantification of Breast RadioTherapy Associated Late Toxicity Using Novel UltraSound Techniques

NCT02388230 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2021-03-10

No results posted yet for this study

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, 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?

Conditions

  • Breast Radiotherapy Toxicity

Interventions

DEVICE

Ultrasound imaging

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • Cambridge University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Emma J Harris, PhD · Institute of Cancer Research, United Kingdom

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2020-04-08
Completion
2020-04-08

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02388230 on ClinicalTrials.gov