Using ultrasound to assess soft tissue changes 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
Universiteit Antwerpen · NCT06180642
This study tests if regular 2D ultrasound can help understand how breast cancer treatment changes soft tissue around the breast and arm in patients, especially looking at those who have or don’t have arm problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universiteit Antwerpen (other) |
| Locations | 1 site (Antwerp) |
| Trial ID | NCT06180642 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the reliability and validity of conventional 2D ultrasound in assessing soft tissue properties, such as composition and thickness, in breast cancer patients. It focuses on understanding how breast cancer treatment affects upper limb function by examining changes in the soft tissue around the breast and axilla. The study will include two groups of breast cancer patients: those without upper limb dysfunctions and those with such dysfunctions, allowing for a comprehensive analysis of the impact of treatment. Participants will undergo ultrasound assessments to gather objective data on their soft tissue properties.
Who should consider this trial
Good fit: Ideal candidates are breast cancer patients who have undergone specific surgical treatments and are at least three months post-surgery without upper limb dysfunctions.
Not a fit: Patients with bilateral breast surgery, widespread metastases, or upper limb dysfunctions caused by other conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved assessment and management of upper limb dysfunctions in breast cancer survivors, enhancing their quality of life.
How similar studies have performed: While the use of ultrasound in assessing soft tissue properties is established, this specific application in breast cancer treatment is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Antwerp
- Universiteit Antwerpen — Antwerp, Belgium (RECRUITING)
Study contacts
- Study coordinator: An De Groef, Prof.
- Email: an.degroef@uantwerpen.be
- Phone: 003216376668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Neoplasms, ultrasound, upper limb dysfunctions