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NCT06180642: SOFT-TI
Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment
trial testing Assessment of soft tissue properties in Breast Neoplasms in 90 participants. Currently enrolling.
2 May 2025
Quick facts
| Lead sponsor | Universiteit Antwerpen |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 90 |
| Start date | 2 May 2023 |
| Primary completion | 2 May 2025 |
| Estimated completion | 2 May 2026 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Assessment of soft tissue properties
- Retest assessment of soft tissue properties
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
Sponsor
Universiteit Antwerpen — full company profile →
Who can join
18 and older, female only, with Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06180642
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06180642 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universiteit Antwerpen
- Last refreshed: 11 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06180642.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing