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

Breast Neoplasms Clinical Trial

— SOFT-TI  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06180642
• Other study ID #: 2776
• Status: Recruiting
• Start date: May 2, 2023
• Est. completion date: May 2, 2025

Study information

• Verified date: December 2023
• Source: Universiteit Antwerpen
• Contact: An De Groef, Prof.
• Phone: 003216376668
• Email: an.degroef[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2, 2025
• Est. primary completion date: May 2, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
Belgium	Universiteit Antwerpen	Antwerpen

Sponsors (2)

Lead Sponsor	Collaborator
Universiteit Antwerpen	KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Reliability of soft tissue composition	Intra- and inter-rater reliability of tissue composition (echo-intensity) measured with 2D ultrasound	1 week
Primary	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	Validity of soft tissue elasticity	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	1 week