Status:
COMPLETED
Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
Lead Sponsor:
Microelastic Ultrasound Systems Inc
Collaborating Sponsors:
Duke Health
Conditions:
Lymphedema of Upper Arm
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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) t...
Eligibility Criteria
Inclusion
- 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
- Active rash or skin tears/injury in bilateral upper extremities
- Subjects with history of contralateral breast cancer treatment
Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05278871
Start Date
May 26 2022
End Date
August 31 2023
Last Update
December 13 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Durham Regional Hospital
Durham, North Carolina, United States, 27704
2
Duke University Medical Center
Durham, North Carolina, United States, 27710