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

NCT06180642 | Recruiting DMC

• 1 other identifier: 2776
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

ultrasound; upper limb dysfunctions

Outcome Measures

Primary Outcomes (3)

• Reliability of soft tissue thickness (mm)

  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

  1 week

• Reliability of soft tissue composition

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

  1 week

• Reliability of soft tissue elasticity (m/sec)

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

  1 week

Secondary Outcomes (1)

• Validity of soft tissue elasticity

  1 week

Study Arms (3)

Women after breast cancer with UL dysfunctions

Other: Assessment of soft tissue properties; Other: Retest assessment of soft tissue properties

Women after breast cancer without UL dysfunctions

Other: Assessment of soft tissue properties; Other: Retest assessment of soft tissue properties

Healthy volunteers

age- and gender-matched control group

Other: Assessment of soft tissue properties; Other: Retest assessment of soft tissue properties

Interventions

Assessment of soft tissue properties OTHER

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

Healthy volunteers; Women after breast cancer with UL dysfunctions; Women after breast cancer without UL dysfunctions

Retest assessment of soft tissue properties OTHER

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

Healthy volunteers; Women after breast cancer with UL dysfunctions; Women after breast cancer without UL dysfunctions

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with history of primary breast cancer
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with a history of primary breast cancer with and without upper limb dysfunctions and an age- and gender-matched healthy control group

You may qualify if:

• 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

You may not qualify if:

• Bilateral surgery, widespread distance metastases, previous breast surgery
• Diagnosis of neurological or rheumatological condition
• upper limb dysfunctions caused by other reasons
• 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
• 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)
• Healthy women (QuickDASH \<15) age-matched with a breast cancer patient from the main study
• Comprehensive of the Dutch language
• upper limb dysfunctions

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• KU Leuven: collaborator

Study Sites (1)

Universiteit Antwerpen

Antwerp, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

An De Groef, Prof.

CONTACT

003216376668; an.degroef@uantwerpen.be

Kaat Verbeelen

CONTACT

kaat.verbeelen@uantwerpen.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: May 2, 2023
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)