Clinical trial · Observational
Multi-Parametric Assessment of Breast Lymphedema
NCT02724514CI-TRIAL-00041967completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Unlike lymphedema in the arm, breast lymphedema is not as well-known and has not been studied. At present, no objective and standardized tools exist to evaluate breast lymphedema. The purpose of this study is to investigate the use of ultrasound analysis and bio-impedance to determine if it is possible to measure the extent of the fluid in the breast.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Lymphedema | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| non-invasive image & bioimpedance based techniques | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Measure Mid-Band Fit (MBF) in normal tissue controls and the corresponding regions of lymphedema
- timeFrame
- 2 years
- description
- The MBF, measured in dB, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure
- measure
- Measure Acoustic Scatterer Diameter (ASD) in normal tissue controls and the corresponding regions of lymphedema
- timeFrame
- 2 years
- description
- The ASD, measured in mm, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 y/o * Diagnosis of lymphedema involving the breast * Diagnosis of in-situ or invasive breast cancer * Female patients following breast conserving therapy and radiotherapy * Spoken and written fluency in English; and * Able to provide informed consent Exclusion Criteria: * Pacemaker or implanted stimulator or other contraindication to bioimpedance analysis * Prior breast surgery on the contra lateral breast * Presence of active cellulitis within the breast, trunk or arm and * Presence of active cancer
References
Publications (0)
Data not yet available
No reference posted for this study.