NCT06180642 Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment
| NCT ID | NCT06180642 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universiteit Antwerpen |
| Condition | Breast Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-05-02 |
| Primary Completion | 2025-05-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2023-05-02 with a primary completion date of 2025-05-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06180642 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06180642 currently recruiting?
Yes, NCT06180642 is actively recruiting participants. Contact the research team at an.degroef@uantwerpen.be for enrollment information.
Where is the NCT06180642 trial being conducted?
This trial is being conducted at Antwerp, Belgium.
Who is sponsoring the NCT06180642 clinical trial?
NCT06180642 is sponsored by Universiteit Antwerpen. The trial plans to enroll 90 participants.