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CompletedNCT05278871Updated Dec 13, 2023

Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

An interventional study of Constructive Shearwave Interference (CSI) in Lymphedema of Upper Arm and Breast Cancer, sponsored by Microelastic Ultrasound Systems Inc. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.

Sponsored by Microelastic Ultrasound Systems Inc · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was Aug 2023, 3 years 1 month ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

02

Conditions studied

  • Lymphedema of Upper Arm
  • Breast Cancer

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03

In context

Breast Neoplasms

12,828 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.

This study's enrollment of 21 is below the median of 72 across 9,498 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with Microelastic Ultrasound Systems Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Active rash or skin tears/injury in bilateral upper extremities
  • Subjects with history of contralateral breast cancer treatment
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    CSI ultrasound measurement

    Participants will have standard volumetric tape measurement across multiple arm locations for lymphedema followed by CSI ultrasound measurements of the same anatomic sites.

    Device: Constructive Shearwave Interference (CSI)

Interventions

  • DeviceConstructive Shearwave Interference (CSI)

    handheld ultrasound

    Also known as: Bullseye Elasticity Quantification

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What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

07

Study locations

2 sites
  • Durham Regional Hospital
    Durham, North Carolina 27704, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
08

References and documents

Publications

  • 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. PubMed 26259888 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2022 to primary completion in Aug 2023, 15 months.

Of 73 industry-sponsored interventional studies with no phase under Breast Neoplasms, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 113. This study's 15 months is below that.

Counting every sponsor, half of 2,347 studies reached it within 34 months; a quarter within 16 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2022
First posted
Mar 14, 2022
StartActual
May 26, 2022
Primary completionActual
Aug 31, 2023
CompletionActual
Aug 31, 2023
Last update
Dec 13, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05278871
Lead sponsor
Microelastic Ultrasound Systems Inc
Collaborators
Duke Health
Responsible party
Sponsor
First posted
Mar 14, 2022
Start date
May 26, 2022
Primary completion
Aug 31, 2023
Completion
Aug 31, 2023
Last update
Dec 13, 2023

Study contacts

Susan McDuff, MD PhD
principal investigator · Duke Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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