Actively Recruiting
Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment
Led by Universiteit Antwerpen · Updated on 2024-12-11
90
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
U
Universiteit Antwerpen
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with unilateral primary breast cancer
- Surgery including mastectomy with axillary lymph node dissection or sentinel lymph node biopsy, or breast conserving surgery with axillary lymph node dissection or sentinel lymph node biopsy
- At least 3 months after surgery or radiotherapy to allow wound healing
- Able to understand and speak Dutch
- QuickDASH score less than 15 out of 100 for patients without upper limb dysfunction
- QuickDASH score greater than 15 out of 100 for patients with upper limb dysfunction
- Healthy women age-matched to breast cancer patients with QuickDASH score less than 15 out of 100
You will not qualify if you...
- Bilateral breast surgery
- Widespread distant metastases
- Previous breast surgery
- Diagnosis of neurological or rheumatological conditions
- Upper limb dysfunction caused by reasons other than breast cancer treatment
- Upper limb dysfunctions in healthy volunteers
- Diagnosis of diabetes in healthy volunteers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Universiteit Antwerpen
Antwerp, Belgium
Actively Recruiting
Research Team
A
An De Groef, Prof.
CONTACT
K
Kaat Verbeelen
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here