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Clinical Trials in Belgium / NCT06180642
Recruiting Observational

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

NCT06180642 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2023-05-02
Last updated
2024-12-11

Condition(s) studied

Breast Neoplasms

Investigational drug(s) / intervention(s)

Assessment of soft tissue propertiesRetest assessment of soft tissue properties

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

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

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
1. Breast cancer patients without upper limb dysfunctions (n=30) Inclusion Criteria * Patients with unilateral primary breast cancer * Surgery including, either: 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 in order to take into account wound healing * Comprehensive of the Dutch language * QuickDASH score \<15/100 Exclusion Criteria: * Bilateral surgery, widespread distance metastases, previous breast surgery * Diagnosis of neurological or rheumatological condition * upper limb dysfunctions caused by other reasons 2. Breast cancer patients with upper limb dysfunctions (n=30) Inclusion Criteria * Patients with unilateral primary breast cancer * Surgery including, either: 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 in order to take into account wound healing * Comprehensive of the Dutch language * QuickDASH score \>15/100 Exclusion Criteria: * Bilateral surgery, widespread distance metastases, previous breast surgery * Diagnosis of neurological or rheumatological condition * upper limb dysfunctions caused by other reasons 3. Healthy volunteers (n=30) Inclusion criteria: * Healthy women (QuickDASH \<15) age-matched with a breast cancer patient from the main study * Comprehensive of the Dutch language Exclusion criteria: * upper limb dysfunctions * Diagnosis of neurological or rheumatological condition, diabetes

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Universiteit Antwerpen Antwerp Belgium Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06180642 on ClinicalTrials.gov ↗ ← All trials in Belgium