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

NCT06180642 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2024-12-11

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

OTHER

Assessment of soft tissue properties

Assessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound

OTHER

Retest assessment of soft tissue properties

Retest Assessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Universiteit Antwerpen

    lead OTHER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2025-05-02
Completion
2026-05-02

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06180642 on ClinicalTrials.gov