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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

Tracking Information
First Submitted Date February 20, 2015
First Posted Date March 13, 2015
Last Update Posted Date February 19, 2020
Study Start Date October 2015
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 9, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Quantification of Breast RadioTherapy Associated Late Toxicity Using Novel UltraSound Techniques
Official Title Quantification of Breast RadioTherapy Associated Late Toxicity Using Novel
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing radiotherapy for breast cancer
Condition Breast Radiotherapy Toxicity
Intervention Device: Ultrasound imaging
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Device: Ultrasound imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 9, 2015)
64
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Emma J Harris, PhD ++442086613320 eharris@icr.ac.uk
Contact: Lone Gothard ++442086613460 lone.gothard@icr.ac.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02388230
Other Study ID Numbers 4220
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Institute of Cancer Research, United Kingdom
Study Sponsor Institute of Cancer Research, United Kingdom
Collaborators
  • Royal Marsden NHS Foundation Trust
  • Cambridge University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Emma J Harris, PhD Institute of Cancer Research, United Kingdom
PRS Account Institute of Cancer Research, United Kingdom
Verification Date August 2019