ICG Lymphography Changes Before and After Radiotherapy in Breast Cancer Patients (ICG_prepostRT)
Prospective Study on ICG Lymphography Changes Before and After Radiotherapy in Breast Cancer Patients
The goal of this observational study is to learn how the lymphatic system changes before and after radiotherapy in female patients with breast cancer. The study aims to understand early lymphatic changes that may lead to breast-cancer-related lymphedema (BCRL) and to help identify patients who might benefit from early preventive rehabilitation.
The main questions it aims to answer are:
How does lymphatic flow and vessel function change after radiotherapy, as measured by indocyanine green (ICG) lymphography?
Can early imaging changes on ICG lymphography predict later swelling or lymphedema symptoms in the arm?
There is no comparison or treatment group, since all participants will receive radiotherapy as part of their standard breast cancer care.
Participants will:
Undergo ICG lymphography before radiotherapy and again within 4-6 weeks after completing radiotherapy
Receive a small injection of ICG dye under the skin and have near-infrared imaging to visualize lymphatic flow
Complete follow-up assessments (for some participants) at 3, 6, or 12 months to monitor long-term lymphatic changes
Continue their usual standard medical and rehabilitation care throughout the study
This study will include 40 female participants, aged 18 years or older, who have been diagnosed with stage I-III breast cancer and are scheduled for postoperative radiotherapy. Participants with a history of lymphedema, prior radiotherapy, severe organ disease, or known ICG/iodine allergy will not be included.
The information collected will include imaging findings from ICG lymphography, arm circumference and volume measurements, and patient-reported outcomes on arm discomfort or swelling. These data will help researchers identify early imaging biomarkers of radiation-induced lymphatic dysfunction.
The study does not involve any experimental treatment or random assignment. All procedures are routine diagnostic or rehabilitation methods that are already approved for clinical use. The ICG test uses a very small amount of dye and is considered safe, with allergic reactions being rare.
The findings of this study may provide new insights into how radiotherapy affects the lymphatic system and may contribute to developing personalized strategies to prevent or minimize lymphedema after breast cancer treatment.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Inah Kim, M.D.,Ph.D
- Número de teléfono: 82-10-2937-6852
- Correo electrónico: inahsylvia@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Yongkyun Jung, M.D.
- Número de teléfono: 82-10-3681-7243
- Correo electrónico: andnfn@naver.com
Ubicaciones de estudio
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Gyeonggido
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Hwaseong-si, Gyeonggido, Corea del Sur, 18450
- Reclutamiento
- Dongtan Sacred Heart Hospital
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Contacto:
- Inah Kim, M.D.,Ph.D
- Número de teléfono: 82-10-2937-6852
- Correo electrónico: inahsylvia@gmail.com
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Contacto:
- Yongkyun Jung, M.D.
- Número de teléfono: 82-10-3681-7243
- Correo electrónico: andnfn@naver.com
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Female breast cancer survivors (stage I-III) scheduled for adjuvant radiotherapy after surgery. Participants are recruited consecutively from the Department of Rehabilitation Medicine, Radiation Oncology and General Surgery at Hallym University Dongtan Sacred Heart Hospital. The study population represents patients at risk for radiation-induced lymphatic dysfunction or breast-cancer-related lymphedema.
Descripción
Inclusion Criteria:
- Female, ≥18 years old
- Pathologically confirmed stage I-III breast cancer
- Scheduled to receive postoperative radiotherapy (RT)
Exclusion Criteria:
- Previous or current lymphedema
- Prior radiotherapy to the ipsilateral breast or axilla
- Severe systemic diseases (heart, renal, hepatic failure)
- Active infection
- Pregnancy or lactation
- Allergy to indocyanine green (ICG) or iodine-based contrast agents
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Lymphatic Function Before and After Radiotherapy Measured by ICG Lymphography
Periodo de tiempo: Baseline (before radiotherapy), 4-6 weeks after completion of radiotherapy, and optionally at 3, 6, and 12 months after RT completion if follow-up imaging is performed.
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Changes in lymphatic function assessed by indocyanine green (ICG) lymphography before and after radiotherapy (RT) including paired T0-to-T1 change in breast indocyanine green (ICG) stage. This reflect radiation-induced lymphatic dysfunction and may serve as early imaging biomarkers for breast-cancer-related lymphedema (BCRL). |
Baseline (before radiotherapy), 4-6 weeks after completion of radiotherapy, and optionally at 3, 6, and 12 months after RT completion if follow-up imaging is performed.
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in other breast ICG findings, Arm Circumference and Limb Volume After Radiotherapy
Periodo de tiempo: Baseline (before radiotherapy), within 14days after radiotherapy completion, 4-6 weeks, and optionally at 3, 6, and 12 months after RT completion
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Change in limb volume (using the truncated cone formula) before and after radiotherapy (RT), compared with baseline measurements. These measurements will be used to determine whether early lymphatic imaging changes are correlated with the development or progression of breast-cancer-related lymphedema (BCRL). |
Baseline (before radiotherapy), within 14days after radiotherapy completion, 4-6 weeks, and optionally at 3, 6, and 12 months after RT completion
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 2025-10-008
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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