Early Diagnosis of Breast Cancer-related Lymphedema

Sponsor
Kaohsiung Veterans General Hospital.
Study ID
NCT06046365
Status
Recruiting
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Conditions

  • Lymphedema

Eligibility Criteria

Sex
FEMALE
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • lymphoscintigraphy — DIAGNOSTIC_TEST
    lymphoscintigraphy
  • circumference measurement — DIAGNOSTIC_TEST
    circumference measurement
  • sonography — DIAGNOSTIC_TEST
    B-mode sono and elastography
  • DXA body composition analysis — DIAGNOSTIC_TEST
    DXA body composition analysis

Study Details

This study will conduct clinical trials to explore the mechanisms behind the development of upper limb lymphedema following breast cancer surgery. The investigators will recruit patients who have undergone breast cancer surgery and utilize Indocyanine Green (ICG) lymphography and Lymphoscintigraphy to identify the locations of lymphatic blockages. Shear Wave Elastography (SWE) will be used to detect changes in tissue limb compliance. DXA body composition analysis will measure the differences in the composition ratios between edematous and normal limbs. In addition, diffusion correlation spectrometry will be employed to monitor changes in deep tissue blood flow, complemented by continuous measurements of limb circumference and other physiological parameters. The study aims to explore the interrelationships among lymphatic circulation, limb circumference, tissue compliance, and tissue blood flow rates.

Key Dates

First listed
Sep 21, 2023
Start date
Oct 24, 2022
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: mastectomy
    Expected to include female patients who are undergoing breast cancer resection surgery or those who have already undergone breast resection surgery for breast cancer.

Primary Outcome Measure

circumference [ Time Frame: everyday, through study completion, an average of 1 year ]

Central Contacts

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