Breast NeoplasmsSOFT-TINCT06180642
Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment
An observational study of Breast Neoplasms, run by Universiteit Antwerpen at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Assessment of soft tissue properties and Retest assessment of soft tissue properties
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 2 May 2023to 2 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
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
Who may be able to join
- Healthy women (QuickDASH <15) age-matched with a breast cancer patient from the main study
- Comprehensive of the Dutch language
Who cannot join
- Bilateral surgery, widespread distance metastases, previous breast surgery
- Diagnosis of neurological or rheumatological condition
- upper limb dysfunctions caused by other reasons
- 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
Show all 15Show fewer
- 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)
- upper limb dysfunctions
- Diagnosis of neurological or rheumatological condition, diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kaat Verbeelen contact
Belgium1 site, 1 recruiting
- Recruiting
Universiteit Antwerpen
Antwerp
An De Groef, Prof., an.degroef@uantwerpen.be
Kaat Verbeelen, kaat.verbeelen@uantwerpen.be
About this study
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
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
- Being tested
- Assessment of soft tissue properties, Retest assessment of soft tissue properties
- Keywords
- ultrasound, upper limb dysfunctions
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of soft tissue propertiesOther
Assessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound
Retest assessment of soft tissue propertiesOther
Retest Assessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Women after breast cancer with UL dysfunctions | Not described Receives: Other: Assessment of soft tissue properties; Other: Retest assessment of soft tissue properties | |
| Women after breast cancer without UL dysfunctions | Not described Receives: Other: Assessment of soft tissue properties; Other: Retest assessment of soft tissue properties | |
| Healthy volunteers | age- and gender-matched control group Receives: Other: Assessment of soft tissue properties; Other: Retest assessment of soft tissue properties |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Reliability of soft tissue composition
Intra- and inter-rater reliability of tissue composition (echo-intensity) measured with 2D ultrasound
Measured: 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
Measured: 1 week
Secondary outcomes (1)
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study start2 May 2023
- Primary completion2 May 2025 (estimated)
- Study completion2 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Principal investigator, An De Groef, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180642
- Sponsor's protocol ID
- 2776
- Acronym
- SOFT-TI
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06180642
- Acronym / sponsor ID
- SOFT-TI / 2776
- Conditions
- Breast Neoplasms
- Keywords
- ultrasound, upper limb dysfunctions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 2 May 2023 (actual)
- Primary completion
- 2 May 2025 (estimated)
- Study completion
- 2 May 2026 (estimated)
- First posted
- 22 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Assessment of soft tissue properties, Other: Retest assessment of soft tissue propertiesage- and gender-matched control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Healthy women (QuickDASH <15) age-matched with a breast cancer patient from the main study
- Comprehensive of the Dutch language
Key exclusion criteria (15 listed)
- Breast cancer patients with upper limb dysfunctions (n=30) Inclusion Criteria
- Healthy volunteers (n=30)
- upper limb dysfunctions
- Diagnosis of neurological or rheumatological condition, diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of soft tissue propertiesAssessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound | Other | Healthy volunteers, Women after breast cancer with UL dysfunctions, Women after breast cancer without UL dysfunctions |
| Retest assessment of soft tissue propertiesRetest Assessment of soft tissue properties at the upper limb region with clinical assessments and ultrasound | Other | Healthy volunteers, Women after breast cancer with UL dysfunctions, Women after breast cancer without UL dysfunctions |
Primary outcome
Reliability of soft tissue thickness (mm)
Time frame: 1 week
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
Reliability of soft tissue composition
Time frame: 1 week
Intra- and inter-rater reliability of tissue composition (echo-intensity) measured with 2D ultrasound
Reliability of soft tissue elasticity (m/sec)
Time frame: 1 week
Intra- and inter-rater reliability of soft tissue elasticity (m/sec) of the pectoralis major muscle and breast measured with shear-wave elastography
1 secondary outcome
Validity of soft tissue elasticity
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaat Verbeelen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact An De Groef, Prof. (003216376668, an.degroef@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of soft tissue thickness (mm) (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.