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Quantification of Breast RadioTherapy Associated Late Toxicity Using Novel UltraSound Techniques (QuaRTUS)

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ClinicalTrials.gov Identifier: NCT02388230
Recruitment Status : Recruiting
First Posted : March 13, 2015
Last Update Posted : February 19, 2020
Sponsor:
Collaborators:
Royal Marsden NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
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?


Condition or disease Intervention/treatment
Breast Radiotherapy Toxicity Device: Ultrasound imaging

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Study Type : Observational
Estimated Enrollment : 64 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantification of Breast RadioTherapy Associated Late Toxicity Using Novel
Study Start Date : October 2015
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Young's modulus (kPa) in the irradiated and non-irradiated breast. [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing radiotherapy for breast cancer
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02388230


Contacts
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Contact: Emma J Harris, PhD ++442086613320 eharris@icr.ac.uk
Contact: Lone Gothard ++442086613460 lone.gothard@icr.ac.uk

Locations
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United Kingdom
The Royal Marsden Recruiting
Sutton, United Kingdom, SM2 5PT
Contact: Lone Gothard         
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Royal Marsden NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Emma J Harris, PhD Institute of Cancer Research, United Kingdom
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Responsible Party: Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT02388230    
Other Study ID Numbers: 4220
First Posted: March 13, 2015    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: August 2019
Keywords provided by Institute of Cancer Research, United Kingdom:
Breast cancer
Elastography
Ultrasound imaging
Quantification of toxicity
Side-effects