Clinical trial · Interventional
Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
A Pilot Study of Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
NCT05278871CI-TRIAL-00072245completedN/AClinicalTrials.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)
This proof of concept study will evaluate the ability of a new, ultrasound based technology called Bullseye Constructive Shearwave Interference (CSI) (trade name, Bullseye Elasticity Quantification) to measure lymphedema of the upper arm among breast cancer survivors. The study's hypothesis is that the CSI device can detect the presence of clinically significant lymphedema when compared with the standard arm tape measurement.
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 |
| Lymphedema of Upper Arm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Constructive Shearwave Interference (CSI) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CSI ultrasound measurement
- description
- Participants will have standard volumetric tape measurement across multiple arm locations for lymphedema followed by CSI ultrasound measurements of the same anatomic sites.
- interventionNames
- Device: Constructive Shearwave Interference (CSI)
Primary outcomes (1)
- measure
- Difference in mean shear wave speed across sites measured between lymphedema and non-lymphedema limbs
- timeFrame
- baseline
- description
- differences in shear wave speed (Bullseye) device measurements between lymphedema affected and non-affected contralateral limb
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any subject with a history of unilateral breast cancer who has completed definitive treatment for breast cancer (i.e. previously undergone surgical resection, with or without adjuvant radiotherapy and/or chemotherapy). Subjects must have completed all recommended adjuvant radiotherapy. Subjects who continue on systemic therapy may be included at the discretion of the treating physician. * Subjects with a history of unilateral axillary sentinel biopsy, lymphadenectomy or dissection are eligible for inclusion. * Subjects taking hormonal therapy are eligible for inclusion * Subject has any stage lymphedema Exclusion Criteria: * Active rash or skin tears/injury in bilateral upper extremities * Subjects with history of contralateral breast cancer treatment
References
Publications (1)
- BACKGROUNDLee SY, Cardones AR, Doherty J, Nightingale K, Palmeri M. Preliminary Results on the Feasibility of Using ARFI/SWEI to Assess Cutaneous Sclerotic Diseases. Ultrasound Med Biol. 2015 Nov;41(11):2806-19. doi: 10.1016/j.ultrasmedbio.2015.06.007. Epub 2015 Aug 8. PMID 26259888