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

Reliability and Validity of Ultrasound for the Assessment of Structural and Mechanical Properties of Soft Tissues at the Upper Limb Region in Women After Breast Cancer Treatment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06180642
Acronym
SOFT-TI
Enrollment
90
Registered
2023-12-22
Start date
2023-05-02
Completion date
2026-05-02
Last updated
2024-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

ultrasound, upper limb dysfunctions

Brief 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.

Interventions

OTHERAssessment of soft tissue properties

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

OTHERRetest assessment of soft tissue properties

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

Sponsors

KU Leuven
CollaboratorOTHER
Universiteit Antwerpen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Reliability of soft tissue thickness (mm)1 weekIntra- and inter-rater reliability of thickness (mm) of the skin, fat tissue, breast parenchyma, retromammary fat, and pectoralis major muscle measured with 2D ultrasound
Reliability of soft tissue composition1 weekIntra- and inter-rater reliability of tissue composition (echo-intensity) measured with 2D ultrasound
Reliability of soft tissue elasticity (m/sec)1 weekIntra- and inter-rater reliability of soft tissue elasticity (m/sec) of the pectoralis major muscle and breast measured with shear-wave elastography

Secondary

MeasureTime frameDescription
Validity of soft tissue elasticity1 weekSoft tissue elasticity (m/sec) measured with the shear-wave elastography will be compared with the soft tissue index (N/m) measured with the MyotonPro, skin stiffness (N) measure with the SkinFibrometer, severity of tissue toxicity after radiotherapy (0-4) with the Late Radiation Morbidity Scoring Scheme (RTOG) and degree of myofascial adhesions (0-9) measured with the MAP-BC

Countries

Belgium

Contacts

Primary ContactAn De Groef, Prof.
an.degroef@uantwerpen.be003216376668
Backup ContactKaat Verbeelen
kaat.verbeelen@uantwerpen.be

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026