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NCT Number: NCT06180642

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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
  • 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

Treatment and study plan

Assessment of soft tissue properties

Other

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

Retest assessment of soft tissue properties

Other

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

Primary outcomes

  1. Reliability of soft tissue thickness (mm)

    Time frame: 1 week

    Intra- and inter-rater reliability of thickness (mm) of the skin, fat tissue, breast parenchyma, retromammary fat, and pectoralis major muscle measured with 2D ultrasound

  2. Reliability of soft tissue composition

    Time frame: 1 week

    Intra- and inter-rater reliability of tissue composition (echo-intensity) measured with 2D ultrasound

  3. Reliability of soft tissue elasticity (m/sec)

    Time frame: 1 week

    Intra- and inter-rater reliability of soft tissue elasticity (m/sec) of the pectoralis major muscle and breast measured with shear-wave elastography

Secondary outcomes

  1. Validity of soft tissue elasticity

    Time frame: 1 week

    Soft 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

Study contacts

Contact information is provided by the study sponsor or research team.

An De Groef, Prof.

CONTACT

[email protected]

003216376668

Kaat Verbeelen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universiteit Antwerpen

Other

Collaborators

  • KU Leuven

Registry information

Official study title

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

Acronym: SOFT-TI

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 22, 2023
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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