Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment
NCT ID: NCT06180642
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
90 participants
OBSERVATIONAL
2023-05-02
2026-05-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Women after breast cancer with UL dysfunctions
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
Women after breast cancer without UL dysfunctions
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
Healthy volunteers
age- and gender-matched control group
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* Healthy women (QuickDASH \<15) age-matched with a breast cancer patient from the main study
* Comprehensive of the Dutch language
Exclusion Criteria
* Diagnosis of neurological or rheumatological condition
* upper limb dysfunctions caused by other reasons
* 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)
* upper limb dysfunctions
* Diagnosis of neurological or rheumatological condition, diabetes
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
KU Leuven
OTHER
Universiteit Antwerpen
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
An De Groef
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universiteit Antwerpen
Antwerp, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
An De Groef, Prof.
Role: primary
Kaat Verbeelen
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2776
Identifier Type: -
Identifier Source: org_study_id