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Elastographic and Ultrasonographic Evaluation of Patients With Breast Cancer Related Lymphedema

M

Marmara University

Status

Completed

Conditions

Lymphedema of Upper Arm
Stiffness of Hand, Not Elsewhere Classified
Evaluations, Diagnostic Self

Treatments

Diagnostic Test: Questioning lymphedema-related symptoms
Other: Extremity circumference and volume measurement
Diagnostic Test: The Lymphedema Life Impact Scale
Diagnostic Test: Quick Dash Questionnare
Diagnostic Test: Shear Wave Elastography and B Mode Ultrasonography

Study type

Observational

Funder types

Other

Identifiers

NCT06009666
07.01.2022.145

Details and patient eligibility

About

The aim of this study is to evaluate the feasibility of shear-wave elastography for the diagnosis and staging of breast cancer related lymphedema by assessing the skin and subcutaneous tissues of the arm and forearm, which could serve as a reference standard and be more easily applicable in daily life; and to investigate the relationship between the patients' symptoms and elastographic measurements.

Full description

Both upper extremities of 72 patients with lymphedema and 72 healthy upper extremities were included in the study. The patients' demographic and clinical data were recorded. The thickness and echogenicity of the skin and subcutaneous tissues of all extremities were evaluated with B-mode ultrasonography, and the stiffness of the skin and subcutaneous tissues was evaluated with shear-wave elastography. The lymphedema arm and the healthy arm of the patients were compared both with each other and with the data of the control group. Interobserver and intraobserver reliability analysis was performed for ultrasonography and elastography measurements. The patients' pain, tension, weight, and stiffness symptoms associated with lymphedema were questioned using a numerical scale. The patients' functionality and participation in daily life activities were evaluated with the Quick DASH and Life Impact Index questionnaires. The relationship between these findings and elastographic and ultrasonographic parameters was analyzed.

Enrollment

72 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

For the patient group

  • between the ages of 18-75
  • diagnosed with breast cancer-associated lymphedema by lymphoscintigraphy
  • being stage 0-1-2 lymphedema according to ISL staging For the control group
  • between the ages of 18-75
  • no history of breast cancer

Exclusion criteria

  • History of surgery in the assessment area
  • History of trauma at the assessment site
  • Active infection in the assessment area
  • Presence of congenital or acquired malformations at the assessment site
  • Primary lymphedema
  • those with any medical condition that may cause edema, such as advanced heart or kidney failure

Trial design

72 participants in 2 patient groups

Patient Group
Description:
Both Extremities of Patients With Breast Cancer Related Lymphedema
Treatment:
Other: Extremity circumference and volume measurement
Diagnostic Test: Questioning lymphedema-related symptoms
Diagnostic Test: The Lymphedema Life Impact Scale
Diagnostic Test: Quick Dash Questionnare
Diagnostic Test: Shear Wave Elastography and B Mode Ultrasonography
Control Group
Description:
Both Extremities of Healthy People With No History of Breast Cancer
Treatment:
Diagnostic Test: Shear Wave Elastography and B Mode Ultrasonography

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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