- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07297927
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Inah Kim, M.D.,Ph.D
- Numéro de téléphone: 82-10-2937-6852
- E-mail: inahsylvia@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Yongkyun Jung, M.D.
- Numéro de téléphone: 82-10-3681-7243
- E-mail: andnfn@naver.com
Lieux d'étude
-
-
Gyeonggido
-
Hwaseong-si, Gyeonggido, Corée du Sud, 18450
- Recrutement
- Dongtan Sacred Heart Hospital
-
Contact:
- Inah Kim, M.D.,Ph.D
- Numéro de téléphone: 82-10-2937-6852
- E-mail: inahsylvia@gmail.com
-
Contact:
- Yongkyun Jung, M.D.
- Numéro de téléphone: 82-10-3681-7243
- E-mail: andnfn@naver.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Lymphatic Function Before and After Radiotherapy Measured by ICG Lymphography
Délai: 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.
|
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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in other breast ICG findings, Arm Circumference and Limb Volume After Radiotherapy
Délai: Baseline (before radiotherapy), within 14days after radiotherapy completion, 4-6 weeks, and optionally at 3, 6, and 12 months after RT completion
|
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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025-10-008
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .