Quantification of Breast RadioTherapy Associated Late Toxicity Using Novel UltraSound Techniques

NCT02388230 | Completed

• 1 other identifier: 4220
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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?

Conditions

Breast Radiotherapy Toxicity

Keywords

Breast cancer; Elastography; Ultrasound imaging; Quantification of toxicity; Side-effects

Outcome Measures

Primary Outcomes (1)

• Young's modulus (kPa) in the irradiated and non-irradiated breast.

  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.

  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.

Study Arms (2)

Patients 4 or more years post radiotherapy

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.

Device: Ultrasound imaging

Patients 0 to 2 years post breast radiotherapy

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.

Device: Ultrasound imaging

Interventions

Ultrasound imaging DEVICE

Patients 0 to 2 years post breast radiotherapy; Patients 4 or more years post radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing radiotherapy for breast cancer

You may qualify if:

• Two patient groups will be included:
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Royal Marsden NHS Foundation Trust: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

The Royal Marsden

Sutton, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Emma J Harris, PhD

  Institute of Cancer Research, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: March 13, 2015
• Study Start: October 1, 2015
• Primary Completion: April 8, 2020
• Study Completion: April 8, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

GB (1)