Early Diagnosis of Breast Cancer-related Lymphedema

NCT06046365 | Recruiting

• 1 other identifier: 22-CT2-15(211230-3)
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphedema

Keywords

lymphoedema; limb circumference; tissue hardness

Outcome Measures

Primary Outcomes (5)

• circumference

  Circumference measurements are taken and recorded at 2 cm intervals from the wrist crease to the armpit on both upper limbs

  everyday, through study completion, an average of 1 year

• Tissue compliance

  Measurements are taken every 5 cm from the wrist crease to the armpit on both upper limbs using ShearWave Elastography

  every 1 week, through study completion, an average of 1 year

• Lymphoscintigraphy

  Golden Standard for diagnosing lymphedema, used for detecting the location of lymphatic circulation blockage

  Once at the beginning of the study, and another assessment will be conducted six months later if there is a deterioration in lymphedema

• Indocyanine green (ICG) lymphography

  Routine examination, used for detecting the type of lymphatic blockage

  Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema

• DXA body composition analysis

  Using DXA to detect and compare the composition of both limbs at different stages after the onset of lymphedema, including changes in protein, fat, and mineral density

  Once at the beginning of the study, and another assessment will be conducted 3 months later if there is a deterioration in lymphedema

Study Arms (1)

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.

Diagnostic Test: lymphoscintigraphy; Diagnostic Test: circumference measurement; Diagnostic Test: sonography; Diagnostic Test: DXA body composition analysis

Interventions

lymphoscintigraphy DIAGNOSTIC_TEST

lymphoscintigraphy

mastectomy

circumference measurement DIAGNOSTIC_TEST

circumference measurement

mastectomy

sonography DIAGNOSTIC_TEST

B-mode sono and elastography

mastectomy

DXA body composition analysis DIAGNOSTIC_TEST

DXA body composition analysis

mastectomy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study aims to recruit 100 breast cancer patients (those who have previously undergone or are expected to undergo any form of breast resection surgery) for research purposes.

You may qualify if:

• Female patients who are expected to undergo breast cancer resection surgery or have already undergone breast resection surgery for breast cancer.
• Absence of unhealed open wounds or other conditions unsuitable for tactile measurements within the measurement area.
• No severe cognitive or emotional impairments.
• No substance abuse (alcohol or drugs).
• Females aged between 20 and 80, capable of fully complying with the requirements of this study plan.

You may not qualify if:

• Presence of unhealed open wounds or other conditions unsuitable for tactile measurements within the measurement area.
• Upper limb abnormalities in function (including joint mobility and muscle strength).
• Significant cognitive, auditory, or expressive language issues that hinder comprehension and compliance with instructions.
• Lack of assistance for daily measurements.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

RECRUITING

MeSH Terms

Conditions

Lymphedema

Interventions

Lymphoscintigraphy; Ultrasonography

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Radionuclide Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Central Study Contacts

Zheng Yu Hoe

CONTACT

+886935517631; jhoe@vghks.gov.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 21, 2023
• Study Start: October 24, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)