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| Name | Class |
|---|---|
| Duke Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSI ultrasound measurement | Experimental | Participants will have standard volumetric tape measurement across multiple arm locations for lymphedema followed by CSI ultrasound measurements of the same anatomic sites. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Constructive Shearwave Interference (CSI) | Device | handheld ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in mean shear wave speed across sites measured between lymphedema and non-lymphedema limbs | differences in shear wave speed (Bullseye) device measurements between lymphedema affected and non-affected contralateral limb | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan McDuff, MD PhD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham Regional Hospital | Durham | North Carolina | 27704 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26259888 | Background | Lee 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Durham |
| North Carolina |
| 27710 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |