Quantification of Breast RadioTherapy Associated Late Toxicity Using Novel UltraSound Techniques

Completed

• Conditions: Breast Radiotherapy Toxicity
• Interventions: Device: Ultrasound imaging

• Registration Number: NCT02388230
• Lead Sponsor: Institute of Cancer Research, United Kingdom

Brief 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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-20
• Study First Submitted QC: 2015-03-09
• Study First Posted: 2015-03-13
• Study Start: 2015-10
• Primary Completion: 2020-04-08
• Study Completion: 2020-04-08
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

Two patient groups will be included:

1. IMPORT or FAST trial patients who received breast RT previously and have received four (or more) year follow-up assessment which found moderate or severe induration.
2. Patients who are (1) undergoing, or undergone recently, breast RT (general population) and have undergone a clinical assessment that found moderate or severe oedema, or (2) IMPORT HIGH patients who have received RT and have received one or two year follow-up which found moderate or severe oedema.

Exclusion Criteria

• Patients with bi-lateral breast cancer.
• Patients who have undergone surgery to the contralateral breast for either benign or malignant conditions.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients 4 or more years post radiotherapy	Ultrasound imaging	IMPORT or FAST trial patients who received breast RT previously and are receiving four years (or more) follow-up assessment and have hardening of their breast as a result of breast radiotherapy.
Patients 0 to 2 years post breast radiotherapy	Ultrasound imaging	Patients who are (1) undergoing, or undergone recently breast RT (general population) and have undergone a clinical assessment either during RT or at 3 month follow-up that found moderate or severe oedema, or (2) IMPORT patients who have received RT and are receiving one or two year follow-up, at which moderate or severe oedema is reported.

Primary Outcome Measures

Name	Time	Method
Young's modulus (kPa) in the irradiated and non-irradiated breast.	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.

Trial Locations

Locations (1)

The Royal Marsden; 🇬🇧 Sutton, United Kingdom