Clinical Trial

Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment

Study acronym: SOFT-TI
Recruiting
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Record status
This record was last updated December 11, 2024 (before its estimated May 2, 2025 completion). Its status may not reflect the trial's current state.
Summary
After 1 year, more than 50% experience upper limb (UL) complaints after treatment for breast cancer. These complaints are disabling and cause limitations in daily life and this leads to a decrease in the patient's quality of life. The cause of these UL complaints is complex and multifactorial. Due to breast cancer treatment, the structural (tissue composition and volume) and mechanical (tissue stiffness) properties of the soft tissue may change. These changes can occur in the muscle, skin and surrounding fascia and especially in the soft tissue around the breast and axilla where that treatment is localised. Ultrasound with specific 'add-on' techniques can objectively assess these features and provide a picture of their role in UL function after breast cancer. The first aim in this study is to investigate the reliability and validity of conventional 2D ultrasound for 1) soft tissue composition and 2) soft tissue thickness at the level of the breast and upper limb. The reliability and validity of shear wave elastography, a specific complement to conventional 2D ultrasound, to assess tissue stiffness will also be examined.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-12-12.
Trial Details
NCT Number NCT06180642
Lead Sponsor Universiteit Antwerpen
Collaborators: KU Leuven
Conditions Breast Neoplasms
Enrollment 90 participants
Start Date 2023-05-02
Primary Completion 2025-05-02 (estimated)
Study Completion 2026-05-02 (estimated)
Updated on ClinicalTrials.gov 2024-12-11